SHOULDER & ELBOW
Surgical treatment of chronic acromioclavicular dislocation with biologic graft vs synthetic ligament: a prospective randomized comparative study
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(7):24 J Orthop Traumatol. 2013 Dec;14(4):283-90. doi: 10.1007/s10195-013-0242-2. Epub 2013 May 740 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.
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)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
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
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
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.
主な研究課題は何ですか？
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?
重要な知見は？
- 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.
最も覚えておくべきことは？
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.
それが私の患者ケアにどのように影響するか？
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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