Meta-analysis
ACE Report #4043

Spine: TDR improves ROM but provides similar outcomes to ACDF for pain and disability


Study Type:ACE Review
OE Level Evidence:N/A
Journal Level of Evidence:N/A

Total Disc Arthroplasty Compared to Anterior Cervical Discectomy and Fusion For the Treatment of Cervical Spine Conditions

Contributing Authors: OrthoEvidence

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Synopsis

18 ACE Reports were identified from the OrthoEvidence database that evaluated cervical total disc replacement (TDR) in comparison to anterior cervical decompression and fusion (ACDF) at a single cervical level. The included trials consisted of 16 randomized controlled trials (RCTs) and 2 meta-analyses. The results of this review indicate that TDR is a safe and efficacious alternative to ACDF, providing similar pain and disability (NDI) improvements, maintenance or improvement in neurological status, and significantly fewer secondary operations at the index level, while allowing for the superior preservation of range of motion in comparison to fusion. Unfortunately due to a lack of trials reporting long-term follow-up outcomes, this review was unable to determine if this preserved range of motion lead to an overall decreased incidence of adjacent level cervical disc disease. Reoperations at adjacent segments were not significantly different between TDR and ACDF. The findings of this review highlighted the need for larger randomized trials to definitively conclude if TDR can provide superior disability and pain outcomes compared to ACDF at both short-term and long-term follow-up periods. Additionally, the necessity for uniform outcome reporting was also emphasized.

Publication Funding Details +
Adjacent segment degeneration incidence uninfluenced by Total Disc Arthroplasty +
Funding:
Non-funded
Sponsor:
Conflicts:
Royalties
The BRYAN cervical disc device is a safe and efficacious treatment for CDD +
Funding:
Industry funded
Sponsor:
Medtronic
Conflicts:
Royalties
ProDisc-C total disc replacement found non-inferior when compared to ACDF +
Funding:
Not Reported
Sponsor:
Conflicts:
None disclosed
Spinal alignment following total disc replacement +
Funding:
Industry funded
Sponsor:
Synthes Spine
Conflicts:
Royalties
Patients have comparable adjacent segment range of motion after ACDF or TDA +
Funding:
Industry funded
Sponsor:
Synthes USA Products.
Conflicts:
None disclosed
Loss of spine segmental motion lower with disc prosthesis vs ACDF for disc herniation +
Funding:
Not Reported
Sponsor:
Conflicts:
None disclosed
Cervical disc disease: artificial disc reduces more pain and disability compared to fusion +
Funding:
Industry funded
Sponsor:
Not listed
Conflicts:
Other
Bryan disc arthroplasty: Viable option for single-level cervical degenerative disc disease +
Funding:
Industry funded
Sponsor:
Not listed
Conflicts:
Other
Total disc replacement preserves cervical ROM while providing excellent clinical outcomes +
Funding:
Non-Industry funded
Sponsor:
Chinese Medical Doctor Association
Conflicts:
None disclosed
Cervical arthroplasty superior to ACDF in neurological and overall success at 24 months +
Funding:
Industry funded
Sponsor:
Not listed
Conflicts:
None disclosed
Similar risk of adjacent segment disease in cervical spine after TDA or ACDF +
Funding:
Non-funded
Sponsor:
Conflicts:
None disclosed
ProDisc-C reduces secondary surgery rate compared to ACDF at 5 years +
Funding:
Industry funded
Sponsor:
Synthes Spine
Conflicts:
Consultant
Short- and mid-term benefits of cervical disc arthroplasty over fusion +
Funding:
Not Reported
Sponsor:
Conflicts:
None disclosed
Cervical spondylosis: Total disk arthroplasty with PCM is an effective alternative to ACDF +
Funding:
Industry funded
Sponsor:
NuVasive, Inc.
Conflicts:
Other
Cervical disc arthroplasty results in improved neurological success, and clinical outcomes +
Funding:
Industry funded
Sponsor:
Medtronic Sofamor Danek
Conflicts:
Other
The in vivo kinematic effects of TDR and anterior cervical discectomy and fusion +
Funding:
Non-funded
Sponsor:
Conflicts:
Royalties
Prestige cervical disc replacement: improved clinical outcomes and segmental motion +
Funding:
Industry funded
Sponsor:
Medtronic Spinal and Biologics.
Conflicts:
Consultant

Report Details and Scores

Adjacent segment degeneration incidence uninfluenced by Total Disc Arthroplasty +

Risk of Bias

7.5/10

Reporting Criteria

14/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

3/4

Outcome Measurements

1/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The BRYAN cervical disc device is a safe and efficacious treatment for CDD +

Risk of Bias

5/10

Reporting Criteria

17/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

ProDisc-C total disc replacement found non-inferior when compared to ACDF +

Risk of Bias

5.5/10

Reporting Criteria

15/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

2/4

Randomization

2/4

Outcome Measurements

3/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Spinal alignment following total disc replacement +

Risk of Bias

5/10

Reporting Criteria

13/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

1/4

Randomization

3/4

Outcome Measurements

2/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Patients have comparable adjacent segment range of motion after ACDF or TDA +

Risk of Bias

6.5/10

Reporting Criteria

18/21

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

4/4

Outcome Measurements

2/4

Inclusion / Exclusion

4/4

Therapy Description

5/5

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Loss of spine segmental motion lower with disc prosthesis vs ACDF for disc herniation +

Risk of Bias

5.5/10

Reporting Criteria

14/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

1/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Cervical disc disease: artificial disc reduces more pain and disability compared to fusion +

Risk of Bias

6/10

Reporting Criteria

12/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

1/4

Randomization

3/4

Outcome Measurements

2/4

Inclusion / Exclusion

4/4

Therapy Description

2/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Bryan disc arthroplasty: Viable option for single-level cervical degenerative disc disease +

Risk of Bias

6.5/10

Reporting Criteria

15/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

1/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Total disc replacement preserves cervical ROM while providing excellent clinical outcomes +

Risk of Bias

5.5/10

Reporting Criteria

17/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

3/4

Outcome Measurements

3/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Cervical arthroplasty superior to ACDF in neurological and overall success at 24 months +

Risk of Bias

5/10

Reporting Criteria

14/20

Were the search methods used to find evidence (original research) on the primary question or questions stated?

Was the search for evidence reasonably comprehensive?

Were the criteria used for deciding which studies to include in the overview reported?

Was the bias in the selection of studies avoided?

Were the criteria used for assessing the validity of the included studies reported?

Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?

Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?

Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?

Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?

How would you rate the scientific quality of this evidence?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Introduction

1/4

Accessing Data

4/4

Analysing Data

3/4

Results

3/4

Discussion

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Comparable clinical outcomes with Bryan Cervical Disc or ACDF for cervical disc disease +

Risk of Bias

5/10

Reporting Criteria

6/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

1/4

Randomization

3/4

Outcome Measurements

0/4

Inclusion / Exclusion

2/4

Therapy Description

0/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Similar risk of adjacent segment disease in cervical spine after TDA or ACDF +

Risk of Bias

7.5/10

Reporting Criteria

16/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

ProDisc-C reduces secondary surgery rate compared to ACDF at 5 years +

Risk of Bias

6/10

Reporting Criteria

15/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

2/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Short- and mid-term benefits of cervical disc arthroplasty over fusion +

Risk of Bias

10/10

Reporting Criteria

18/20

Were the search methods used to find evidence (original research) on the primary question or questions stated?

Was the search for evidence reasonably comprehensive?

Were the criteria used for deciding which studies to include in the overview reported?

Was the bias in the selection of studies avoided?

Were the criteria used for assessing the validity of the included studies reported?

Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?

Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?

Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?

Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?

How would you rate the scientific quality of this evidence?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

4/4

Introduction

4/4

Accessing Data

4/4

Analysing Data

3/4

Results

3/4

Discussion

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Cervical spondylosis: Total disk arthroplasty with PCM is an effective alternative to ACDF +

Risk of Bias

5.5/10

Reporting Criteria

13/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

1/4

Randomization

2/4

Outcome Measurements

2/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Cervical disc arthroplasty results in improved neurological success, and clinical outcomes +

Risk of Bias

4.5/10

Reporting Criteria

15/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

3/4

Outcome Measurements

2/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The in vivo kinematic effects of TDR and anterior cervical discectomy and fusion +

Risk of Bias

5/10

Reporting Criteria

13/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

1/4

Randomization

3/4

Outcome Measurements

2/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Prestige cervical disc replacement: improved clinical outcomes and segmental motion +

Risk of Bias

4/10

Reporting Criteria

15/20

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

1/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

Background

Cervical total disc arthroplasty has been suggested as an excellent alternative to anterior cervical decompression and fusion (ACDF) in the treatment of degenerative disc disease and other cervical spine conditions. While ACDF has been proven to provide significant reductions in both pain and disability, it is associated with a reduction in cervical ROM at the operative level, which may lead to complications for adjacent vertebrae and the eventual progression of degeneration. Recent research findings have demonstrated that TDR can retain the cervical ROM at the operative level and may provide similar reductions in pain and disability, potentially preventing the progression of adjacent level degeneration. This review was necessary to assess the current high quality evidence available in order to determine if TDR does provide any significant improvements over the current standard, and if these differences are clinically significant.

What was the principal research question?

Is total disc replacement a safe and efficacious alternative to anterior cervical decompression and fusion for the treatment of single level cervical spine conditions? Additionally, does TDR provide any significant advantages when compared to ACDF?

Study Characteristics -
Report Characteristics:
18 reports were identified that assessed the use of total disc replacement (including Bryan Cervical Disc, Prodisc-C, Kineflex-C, Prestige ST Artificial Disc, PCM Cervical Disc, Mobi-C Cervical Disc, and Advent Cervical Disc) for cervical spine conditions. Two meta-analyses and 16 randomized control trials were included. The publication dates ranged from January 2006 - July 2013. A total of 2583 patients were identified from the RCTs.
Report Selection:
The following terms were used to search the OrthoEvidence database; "total disc arthroplasty', "total disc replacement", and "cervical disc arthroplasty". The search resulted in the identification of 42 reports for possible inclusion. Screening using the inclusion criteria led to the exclusion of 24 reports, leaving 18 reports for final inclusion. Inclusion criteria were: studies that (1) assessed the use of TDR in comparison to ACDF at a single level of the cervical spine, (2) had a minimum follow-up of 6 months, (3) and that reported one of pain, disability, range of motion, adverse events or adjacent level cervical disc degeneration.
Outcomes:
Outcomes assessed in the included trials were: the Neck Disability Index (NDI), Neck Pain and Arm Pain, neurological success, secondary surgeries at index and adjacent level(s), SF-36, range of motion, adverse events, and development of adjacent level degeneration and adjacent level disease.
Heterogeneity:
Heterogeneity was assessed using the I squared statistic for outcomes where pooling was acceptable.

Pooling and statistical Analysis

  • The results from all trials indicated that both treatments provided significant improvements in pain and disability compared to preoperative values.
  • Four studies were pooled for Neck Disability Index outcomes at 24 months (n=1155). The analysis indicated no significant difference between groups (MD -1.34 (95%CI -3.07 to 0.39); P=0.13). Moderate heterogeneity was noted (I-squared=35%). Six studies were additionally analyzed qualitatively. Sasso et al. reported significantly lower NDI scores after 24 month in the group treated with TDR compared to ACDF (P=0.005). However, 2 studies (Phillips et al. and Coric et al.) observed no significant difference between groups after 24 months. At longer-term follow-up (4-5 years), Jawahar et al. and Zigler et al. reported similar NDI outcomes for both groups. In contrast, Burkus et al. observed significantly lower NDI scores in TDR patients after 5 years (P=0.022). In 4 of 5 studies which reported immediate short-term outcome (6 weeks - 3 months), NDI scores of the TDR groups were reported to be significantly lower than those in the ACDF groups at one or both of these follow-up periods.
  • Four studies were included in the pooling for neck pain scores. Two studies were pooled at 6-12 months (n=142), and indicated that there was no significant difference between TDR and ACDF in this time frame (MD 3.16 (95%CI -6.16 to 12.49); P=0.51). Significant heterogeneity was observed (I-squared=96%). Three studies were pooled at 24 months (n=954), and indicated a significant difference between treatments in favour of TDR (MD -2.62 (95%CI -4.85 to -0.40); P=0.02). Heterogeneity was not significant (I-squared=17%). An additional six studies provided data on neck pain outcome, although were ineligible for pooling. Sasso et al. illustrated significantly lower pain scores in those treated with TDR after 24 months (P=0.005), while in contrast 2 studies (Murrey et al. and Coric et al.) displayed no significant difference between treatments after 24 months. Over longer-term follow-up, Zigler et al. found significantly lower pain scores with TDR treatment after 5 years (P=0.0122), and Burkus et al. demonstrated lower neck pain scores for TDR treatment, although the level of significance was not indicated. Jawahar et al. reported no significant difference between TDR and ACDF after follow-up of 48 months.
  • Four studies were included in the pooling for arm pain scores. Two studies were pooled at 6-12 months (n=142), and indicated that there was no significant difference between TDR and ACDF in this time frame (MD -1.38 (95%CI -4.51 to 1.75); P=0.39). Significant heterogeneity was observed (I2=86%). Three studies were pooled at 24 months (n=954), and indicated there was no significant difference between groups (MD -1.15(95%CI -2.62 to -0.32); P=0.12). Heterogeneity was not significant (I2=0%). An additional five studies reported arm pain outcome that were not included in the pooled analysis. Murrey et al. and Coric et al. observed similar arm pain scores between groups after 2 years, and both Burkus et al. and Zigler et al. found no significant difference after 5 year follow-up. However, Sasso et al. reported significantly lower arm pain level in the group treated with TDR compared ACDF (P=0.014).
  • Results from 5 of the included trials were pooled regarding neurological success (n=1387). A total of 693/742 patients who received TDR treatment achieved neurological success at 2 years, compared to 567/645 patients who received treatment with ACDF. The analysis indicated that treatment with TDR lead to significantly greater neurological success at 2 years when compared to treatment with ACDF (p=0.001, I-squared=0%). However, it should be noted that pooled results from 2 studies, with 5 year follow up periods, demonstrated no significant difference between the two treatment methods regarding neurological success (202/216 TDR vs. 169/188 ACDF) (p=0.39, I-squared=39%).
  • Results from 4 studies regarding secondary surgery at the index level were pooled (n=1283). A total of 13/665 patients who received TDR underwent surgery at the index level compared to 40/618 patients who underwent ACDF. The analysis indicated that significantly less secondary surgeries at the index level occurred in patients receiving TDR within 24 months of treatment (p=0.0005, I-squared=0%). Pooled results from 2 separate studies (n=750), reporting their findings within 60 months, produced similar results to those in the 24 month analysis, once again showing that the TDR treatment resulted in few secondary surgeries at the index level (21/379 TDR vs. 65/371 ACDF) (p<0.00001, I-squared=0%). The overall finding, regarding secondary surgery at the index level, was in favour of the TDR treatment (p<0.00001, I-squared=0%).
  • Five studies were pooled for incidence of secondary surgeries at adjacent disc levels (n=1437). A total of 12/733 patients who received TDR underwent reoperations at an adjacent level, compared to 23/704 ACDF. The analysis indicated a trend toward significant difference in favour of TDR treatment, however significance was not reached (OR 0.52 (95%CI 0.25-1.07); P=0.08). Heterogeneity was not present in the analysis (I2=0%).
  • Pooled results from 2 of the included trials indicated no difference between TDR and ACDF treatments regarding SF-36 physical component scores, 24 months after treatment (p=0.22, I-squared= 0%).
  • Range of motion (ROM) at the index level was reported in 7 trials. The results from all of the trials indicated that TDR led to maintenance of the preoperative range of motion at the index level, whereas ACDF led to a significant decrease in ROM at the index level.
  • Data on adjacent segment degeneration and adjacent segment disease were reported in three of the included studies. Phillips et al. reported development of adjacent level degeneration at either the superior or inferior segment in 39.1% of TDR patients and 49.2% of ACDF patients after 2 years (P=0.111). Jawahar et al. (n=93 patients) reported development of adjacent level disease in 18% of TDR patients and 15% of ACDF patients, which was not a significant difference (P=0.885). In a serial study by Nunley et al. (n=182), the rates were reported to be 17% and 14%, respectively. Concurrent lumbar degenerative disc disease was reported to significantly increase the risk of developing adjacent segment disease (P=0.02).
  • Eight studies reported adverse events. Seven of these studies indicated no differences between procedures. One study reported slightly more adverse events in the TDR group relating to surgery, while there were more serious complications and re-operations in the ACDF group.
  • The findings from the two meta-analyses indicated similar findings to those observed in this report.

Main Findings

Forest Plot: Neck Disability Index at 24 months

Forest Plot: Neck Pain Scores

Forest Plot: Arm Pain Scores

Forest Plot: Neurological Success

Forest Plot: Secondary Surgeries at Index Level

What should I remember most?

The results from this review have demonstrated that both TDR and ACDF lead to significant improvements in pain and disability scores in patients with single level cervical spine conditions when compared to preoperative levels. Disability measured using the NDI was not significantly different between TDR and ACDF from pooled results of outcome at 24 months, while qualitatively there was contrasting evidence of the comparative efficacy between the two treatments, with both statistical significance and non-significance reported. It remains unclear if differences in disability between these two procedures were clinically relevant. Pooled pain assessment illustrated that TDR provided a significant reduction in neck pain compared to ACDF at 24 months, although qualitative analysis displayed contrasting evidence, both at short- and long-term. It remains to be determined if the differences observed were clinically significant There did not appear to be any significant difference between treatments regarding postoperative arm pain. Neurological outcome appeared to be significantly better with TDR treatment, and resulted in significantly fewer secondary surgeries at the index level. The difference between TDR and ACDF did not reach statistical significance regarding secondary surgeries performed at adjacent segments. Range of motion at the index level was preserved in the TDR patients in comparison to ACDF treatments which may have provided superior long term benefits and reduce the prevalence of adjacent level disc degeneration. However, the rates of developing adjacent segment degeneration and disease were found to be similar between treatments, although this was reported in just three studies in which the follow-up duration was relatively short.

Implications for patient treatment and future research:

The results from this review indicate that both treatments provide significant improvements in pain and disability for patients with TDR allowing for the maintenance of range of motion at the operative level. However, further long-term assessments of high methodological quality are needed to determine if this preservation in ROM can decrease the incidence of adjacent level disc degeneration. The results from this review additionally demonstrate the need for standard outcome reporting guidelines within the literature to improve comparisons between trials.

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luc racine 2017-08-06 7:16 PM

Orthopaedic Surgeon - Canada

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