SPORTS MEDICINE
Primary Repair Versus Conservative Treatment of First-Time Traumatic Anterior Dislocation of the Shoulder: A Randomized Study With 10-Year Follow-up
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):273 Arthroscopy. 2007 Feb;23(2):118-23.76 patients with first-time traumatic anterior dislocation of the shoulder joint were randomized to either receive open Bankart surgical repair, or conservative treatment. This study aimed to compare rates of recurrence between treatments. The results at both the two year and ten year follow up periods indicated that open repair reduced the recurrence rate of shoulder dislocations in comparison to conservative treatment.
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。
1/4
Randomization
2/4
Outcome Measurements
3/4
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
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？
Dislocations of the shoulder joint are the most frequent type of dislocations in the body. With traumatic anterior dislocation, there is a high risk recurrence; however, it is still uncertain if surgical repair of Bankart lesions produces a significant reduction in recurrence compared to conservative treatment. Recurrent instability of the shoulder joint can negatively affect one's performance in daily activities as well as sports. This study is of importance, as there have been few long-term, high quality studies looking at surgical versus conservative treatments.
主な研究課題は何ですか？
Does open Bankart surgical repair of lesions reduce the rate of recurrence of dislocations, as compared to conservative treatment, in patients with traumatic anterior shoulder dislocations, over a ten year follow up period?
重要な知見は？
- At the two year follow up period, 1 of 37 (2.7%) in the Open Bankart repair group had a recurrent anterior dislocation whereas this was present in 21 of 39 (53.8%) of those in the non-surgical group (p=0.0011). All of these patients who had re-dislocations had Baker type 2 or 3 lesions.
- No significant difference was seen in remaining non-dislocators between both groups with respect to Constant scores.
- Of the 36 patients in the Bankart repair group without dislocations, 7% had positive apprehension test, and 4% had a grade 1 load-and-shift test.
- Out of those who did not sustain a redislocation in the nonsurgical group, 39% had a positive apprehension test, and 39% had a grade 1 or 2 load-and-shift test.
- 80% with Type 2 lesions, and 53% with Type 3 lesions (in nonsurgical group) sustained a recurrence within two years following trauma.
- At the ten year follow up period (completed telephone interview and questionnaire), 9% of patients in repair group had recurrent dislocation. When grading was completed using the Oxford Shoulder Score, 53% had excellent results and 17% had good results.
- In the nonsurgical group, 62% patients sustained recurrent anterior dislocation. 74% had unsatisfactory results due to instability or pain (Oxford scale) at the ten year follow up period.
最も覚えておくべきことは？
Open Bankart repair as treatment for anterior dislocations of the shoulder joint, yielded lower rates of recurrence, as compared to conservative treatment. These results were seen at both the two year and ten year follow up periods.
それが私の患者ケアにどのように影響するか？
The results of this study indicated that open repair was a more effective treatment as compared to a conservative method in reducing rate of redislocation, in a population of young individuals with anterior shoulder dislocation.
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