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

Not Applicable

Completed

• Conditions: SLAP Lesions
• Interventions: Procedure: biceps tenodesis; Procedure: labral repair; Procedure: diagnostic arthroscopy

• Registration Number: NCT00586742
• Lead Sponsor: Lovisenberg Diakonale Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2007-12-21
• Study Start: 2008-01
• Study First Submitted QC: 2008-01-03
• Study First Posted: 2008-01-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	biceps tenodesis	Biceps tenodesis with suture anchor
1	labral repair	Labral repair with suture anchors
3	diagnostic arthroscopy	only a diagnostic arthroscopy performed

Primary Outcome Measures

Name	Time	Method
WOSI score Constant score EQ-5D Rowe score Patient Satisfaction	6 and 24 months

Secondary Outcome Measures

Name	Time	Method
Sick leave Time back to sports at preoperative level	6 and 24 months

Trial Locations

Locations (1)

Lovisenberg Diakonale Hospital; 🇳🇴 Oslo, Norway