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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Labral repair with suture anchors |
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| 2 | Active Comparator | Biceps tenodesis with suture anchor |
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| 3 | Sham Comparator | only a diagnostic arthroscopy performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| labral repair | Procedure | labral repair with suture anchors |
|
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| Measure | Description | Time Frame |
|---|---|---|
| WOSI score Constant score EQ-5D Rowe score Patient Satisfaction | 6 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sick leave Time back to sports at preoperative level | 6 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:earlier shoulder procedures,
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| Name | Affiliation | Role |
|---|---|---|
| cecilie p schrøder, MD | Lovisenberg Diakonale Hospital | Principal Investigator |
| Jens i Brox, MD, PhD | University of Oslo, Rikshospitalet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lovisenberg Diakonale Hospital | Oslo | Oslo | 0789 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32241790 | Derived | Brox JI, Skare O, Mowinckel P, Brox JS, Reikeras O, Schroder CP. Sick leave and return to work after surgery for type II SLAP lesions of the shoulder: a secondary analysis of a randomised sham-controlled study. BMJ Open. 2020 Apr 1;10(4):e035259. doi: 10.1136/bmjopen-2019-035259. | |
| 28495804 | Derived | Schroder CP, Skare O, Reikeras O, Mowinckel P, Brox JI. Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial. Br J Sports Med. 2017 Dec;51(24):1759-1766. doi: 10.1136/bjsports-2016-097098. Epub 2017 May 11. |
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| ID | Term |
|---|---|
| D053441 | Suture Anchors |
| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
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| biceps tenodesis | Procedure | biceps tenodesis with suture anchor |
|
|
| diagnostic arthroscopy | Procedure | diagnostic arthroscopy |
|
| 20929552 | Derived | Skare O, Schroder CP, Reikeras O, Mowinckel P, Brox JI. Efficacy of labral repair, biceps tenodesis, and diagnostic arthroscopy for SLAP lesions of the shoulder: a randomised controlled trial. BMC Musculoskelet Disord. 2010 Oct 7;11:228. doi: 10.1186/1471-2474-11-228. |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |