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Volume:3 Issue:4 Number:4 ISSN#:2563-5476
RCT
ACE Report #5928

Biologic grafts are suitable alternatives to synthetic ligaments in AC joint stabilization


How to Cite

OrthoEvidence. Biologic grafts are suitable alternatives to synthetic ligaments in AC joint stabilization. ACE Report. 2014;3(4):4. Available from: https://myorthoevidene.com/AceReport/Report/5928

Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Surgical treatment of chronic acromioclavicular dislocation with biologic graft vs synthetic ligament: a prospective randomized comparative study

J Orthop Traumatol. 2013 Dec;14(4):283-90. doi: 10.1007/s10195-013-0242-2. Epub 2013 May 7

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Synopsis

40 patients with a complete and chronic acromioclavicular (AC) dislocations were randomized to undergo surgical AC joint stabilization using either a biological graft (semitendinosus) or a synthetic ligament. The purpose was to compare these two techniques with respect to clinical and radiological outcomes. Results indicated that patients undergoing the procedure with a biological graft had significantly better Constant-Murley scores at 1 year compared to those who underwent the procedure using a synthetic ligament. This difference was not significant at the 4-year follow-up. Clinical scores did not correlate with the number of subluxated shoulders, coracoclavicular ossification, AC joint osteoarthritis, or clavicular osteolysis. Furthermore, patient satisfaction was not related to the degree of AC joint reduction.

Publication Funding Details +
Funding:
Not Reported
Conflicts:
None disclosed

Risk of Bias

6/10

Reporting Criteria

17/20

Fragility Index

N/A

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

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?

An acromioclavicular (AC) dislocation is considered chronic when it remains untreated, is treated conservatively, or for which surgical treatment proved to be unsuccessful. Shoulder instability, which occurs when the coracoclavicular ligaments counteract the AC joint laxity, may result in patients suffering from a chronic AC dislocation. As a result, surgical intervention may be required; however, the optimal surgical technique remains unknown. This study was needed to compare clinical and radiological outcomes when surgical AC joint stabilization was performed using a biologic graft or a synthetic ligament.

What was the principal research question?

How does a synthetic ligament compare to a biologic graft, with respect to clinical and radiological outcomes, in patients undergoing surgical acromioclavicular (AC) joint stabilization?

Study Characteristics -
Population:
40 patients (below the age of 60) with a complete (Rockwood et al. classification Type III or higher) and chronic acromioclavicular (AC) dislocation.
Intervention:
Group A: Patients in this group (n=20) underwent surgical AC joint stabilization using a biological graft. A semitendinosus graft (Rizzoli Orthopaedic Institute, Bologna, Italy) was used and was fixed to the clavicle with polylactic acid screws (Arthrex, Naples, FL, USA; diameter: 4.5-10 mm; length: 5.7-15 mm). The lateral portion of the graft was fixed to the acromion using trans-osseous sutures. Patients in this group followed the same rehabilitation protocol as those in the control group. (Mean age: 36 +/- 4.3 years) (15 males, 5 females)
Comparison:
Group B: Patients in this group (n=20) underwent surgical AC joint stabilization using a synthetic ligament (LARS LAC, Arc sur Tille, France). This synthetic ligament was 20 mm in diameter and was fixed to the clavicle with titanium screws (diameter: 4.7-5.7 mm; length: 15 mm) (Mean age: 34 +/- 2.8 years) (10 males, 10 females). Passive immobilization was allowed after 1 month, active exercise in a water pool was permitted after 40 days, and strength exercises were allowed at 75 days.
Outcomes:
Clinical outcomes included the Constant-Murley score, the modified UCLA scores, and patient satisfaction. The radiological outcomes assessed in this study were: AC joint stability in the coronal and axial planes (via anteroposterior and axillary views), coracoclavicular ossification (either complete or incomplete), signs of osteoarthritis, and distal clavicular osteolysis (i.e. signs of demineralization around the screws or on the lateral portion of the clavicle. As per the Rosenorm and Pedersen criteria, the AC joint was considered to be: (1) stable if it showed no dislocation compared to the contralateral joint, (2) subluxated if the dislocation was less than or equal to 50% of the contralateral joint, or (3) dislocated if there was complete dislocation accounting for greater or equal to 100% of the AC joint surface.
Methods:
RCT; Single Center
Time:
Clinical assessments and x-rays were performed 1 and 4 years. X-rays were also collected at 2 months.

What were the important findings?

  • Constant-Murley scores were significantly increased in both groups from baseline (Group A: 43.5 +/- 6.1; Group B: 44.05 +/- 8.9) to 1 year (Group A: 88 +/- 10, p=0.0097; Group B: 59 +/- 7.9, p=0.0049) and 4 years (Group A: 94.2 +/- 4.9, p=0.0093; Group B: 85.9 +/- 16, p=0.0089). There was a significant between-group difference at 1 year (p=0.0092) favouring group A, however this statistical significance was lost at 4 years (p=0.0626).
  • In Group A, UCLA scores were 17.8 +/- 1.8 and 18.2 +/- 1.7 at 1 and 4 years, respectively. Group B UCLA scores were 11.8 +/- 4.9 and 15.4 +/- 4.2 at 1 and 4 years, respectively.
  • 85% (17) of patients in Group A and 55% (14) of patients in Group B had "good" patient satisfaction. Improvement was significant at 1 (p=0.011) and 4 years (p=0.014) in both groups. Satisfaction was not related to the degree of AC joint reduction.
  • Immediately following surgery, radiological imaging revealed that 19 patients in Group A (95%) and 12 patients in Group B (60%) had stable AC joints.
  • At 2 months, in Group A, one shoulder had subluxated, and another had completely dislocated. At 1 year, an additional 3 patients in this group (20%) had suffered a subluxation. No other cases of instability were recorded at 4 years (i.e. total number of subluxations and complete dislocations at study completion were 4 and 1, respectively). The number of subluxated shoulders at 4 years did not correlate with clinical scores.
  • At 2 months, in Group B, complete dislocation was found in 1 patient (5%) and subluxation was observed in another patient (5%). At 1 year, an additional 3 patients (20%) had suffered a subluxation and an additional 1 patient (5%) had suffered a complete dislocation. No other cases of instability were recorded at 4 years (i.e. total number of subluxations and complete dislocations at study completion were 4 and 2, respectively). The number of subluxated shoulders at 4 years did not correlate with clinical scores.
  • Incomplete coracoid ossification was found in 5 patients (25%) at 1 year in Group A, as well as in 7 patients (35%) at 1 year and in 1 patient (5%) at 4 years in Group B. There was no correlation between clinical scores and coracoclavicular ossification.
  • At 1 year, 4 patients (20%) in Group A and 11 patients (55%) in Group B were found to have an arthritic AC joint. At 4 years, these numbers were 8 (40%) and 2 (10%) in Groups A and B, respectively. There was no correlation between clinical scores and AC joint osteoarthritis.
  • At 2 months, two patients (10%) in Group B displayed osteolysis around the screws.These numbers were 5 (20%) in Group A and 16 (80%) in Group B at 1 year, and 13 (65%) in Group A and 20 (100%) in Group B at 4 years. There was no correlation between clinical scores and clavicular osteolysis.

What should I remember most?

Patients undergoing surgical acromioclavicular (AC) joint stabilization with a biological graft had significantly better Constant-Murley scores at 1 year compared to those who underwent the procedure using a synthetic ligament. This difference was not significant at the 4-year follow-up. Clinical scores did not correlate with the number of subluxated shoulders, coracoclavicular ossification, AC joint osteoarthritis, or clavicular osteolysis. Furthermore, patient satisfaction was not related to the degree of AC joint reduction.

How will this affect the care of my patients?

Results from this study suggest biological grafts are a suitable alternative to synthetic ligaments in surgical acromioclavicular (AC) joint stabilization procedures, however additional studies with larger sample sizes are required to confirm these findings. Future studies should also focus on improving graft fixation to the clavicle regardless of the technique being used.

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