SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether there is a difference between conservative and operative treatment of Superior Labral Lesions(SLAP)of the shoulder.

Detailed Description
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Treatment of superior labral lesions is controversial. Some authors advocate labral repair, some advocate biceps tenodesis,and others again questions whether these lesions should be repaired at all. There are no randomized studies comparing operative treatment and conservative treatment(i.e. physical rehabilitation), and likewise no randomized studies comparing labral repair and biceps tenodesis. In this study;all patients who have a patient history, clinical signs of a SLAP lesion,a MRI study revealing an isolated superior labral lesion and have agreed to participate in the study, will have a diagnostic arthroscopy performed. If a SLAP lesion is diagnosed, the patients are randomized to three different groups:1) SLAP repair with suture anchors 2) Biceps tenodesis 3) Physical therapy

Official Title
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SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study

Conditions
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SLAP Lesions

Intervention / Treatment
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* Procedure: labral repair
* Procedure: biceps tenodesis
* Procedure: diagnostic arthroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical history and signs of superior labral lesion MRI study revealing an isolated superior labral lesion Exclusion Criteria:earlier shoulder procedures, Other accompanying shoulderpathologies(such as cufflesions, instability, ac-joint pain, arthritis)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Labral repair with suture anchors | Procedure: labral repair<br>* labral repair with suture anchors<br>* Other names: lupine anchor;|
| Active Comparator: 2<br>Biceps tenodesis with suture anchor | Procedure: biceps tenodesis<br>* biceps tenodesis with suture anchor<br>* Other names: suture anchor;|
| Sham Comparator: 3<br>only a diagnostic arthroscopy performed | Procedure: diagnostic arthroscopy<br>* diagnostic arthroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOSI score Constant score EQ-5D Rowe score Patient Satisfaction |  | 6 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sick leave Time back to sports at preoperative level |  | 6 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLAP lesions, labral repair, bicepstenodesis, conservative treatment