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Adjacent segment degeneration incidence uninfluenced by Total Disc Arthroplasty
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June 2013
Adjacent segment degeneration incidence uninfluenced by Total Disc Arthroplasty
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
Total disc arthroplasty does not affect the incidence of adjacent segment degeneration in cervical spine: Results of 93 patients in three prospective randomized clinical trials
Spine Journal; 2010; 10; 1043-1048Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
93 patients, with mono or bi-level cervical disc symptomatic disease and upon failure of conservative treatment, were randomized to undergo total disc arthroplasty (TDA) or anterior cervical discectomy and fusion (ACDF). Primary Outcome Measures were Visual Analogue Score (VAS), Neck Disability Index and Radiographic Assessment were made at different time points until 48 months. Both the ACDF and TDA procedures were found to be equivalent for rendering pain relief in both mono and bi level disc disease and had equivalent risks for inducing adjacent segment degeneration. Interestingly, it was observed that patients with concurrent degenerative disc disease of the lumbar spine had greater likelihood of developing adjacent segment degeneration.
Publication Funding Details
+
Funding:
Non-funded
Conflicts:
Royalties
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 Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Anterior cervical discectomy and fusion (ACDF) is an established treatment for the degenerative disc disease of the cervical spine; however, the development of implants and procedures to restore motion, segmental anatomy, and function shows success after further investigation. The purpose of this study was to compare the incidence of adjacent segment disease in patients treated for degenerative disc disease with either total disc arthroplasty or anterior cervical discectomy and fusion.
What was the principal research question?
Is there a difference in incidence of adjacent segment disease after patients with degenerative disc disease are treated with either total disc arthroplasty or anterior cervical discectomy and fusion?
Study Characteristics
-
Population:
93 patients with symptomatic mono or bi-level cervical disc disease and failed 6 month conservative treatment
Intervention:
Total disc arthroplasty (TDA) Group: TDA was performed using the following implant devices: Kineflex-C (SpinalMotion Inc., Mountain View, CA, USA), Mobi-C (LDR spine, Austin, TX, USA), and Advent Cervical Disc (Blackstone Inc., Parsippany, NJ, USA) (n=69) M/F=21/38
Comparison:
Anterior cervical discectomy and fusion (ACDF): ACDF was performed using the modified Smith Robinson technique, using cortical bone allograft and anterior plating. Demineralized bone matrix and bone morphogenetic protein was not permitted (n=24) M/F=16/18
Outcomes:
Success of index surgery was assessed by Visual Analog Pain Score (VAS) pain, Neck Disability Index, and Cervical spine radiographs
Methods:
Prospective, Blinded, Randomized, FDA IDE Trial
Time:
2 years (6 weeks, 3, 6, 12, 24, 36 and 48 months)
What were the important findings?
- The success rates were similar in procedures, 71% in TDA and 73.5% in ACDF, and median symptom-free survival period was 39.79+/-1.9 months for ACDF and 38.09+/- 1.9 months for TDA patients. Smokers had a trend towards worse survival rates (p=0.17) for both procedures.
- VAS and NDI scale were similar between groups (p-value = 0.693)
- No statistical difference was noted between groups in terms of development of adjacent lumbar disease (p-value = 0.885)
- Presence of documented lumbar disease was a statistically significant risk factor for development of adjacent lumbar disease (p-value = 0.016)
What should I remember most?
Total disc arthroplasty and anterior cervical discectomy and fusion have the same clinical outcomes. However, lumbar disease increases the risk of adjacent cervical degenerative disc disease.
How will this affect the care of my patients?
This study suggests that both techniques are equivalent in treating degenerative disc disease and do not increase risk of adjacent lumbar disease compared to one another. The study also notes that lumbar disease is a significant risk factor for development of adjacent cervical degenerative disc disease. Therefore, it is recommended that physicians consider other factors before considering which treatment is most appropriate for patients.
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