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

Lovisenberg Diakonale Hospital

Status: Completed

Conditions: SLAP Lesions

Treatments: Procedure: diagnostic arthroscopy; Procedure: labral repair; Procedure: biceps tenodesis

Study type: Interventional

Funder types: Other

Identifiers

NCT00586742

IRB00001870

Details and patient eligibility

About

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.

Full 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

Enrollment: 118 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 3 patient groups

1

Active Comparator group

Description:

Labral repair with suture anchors

Treatment:

Procedure: labral repair

2

Active Comparator group

Description:

Biceps tenodesis with suture anchor

Treatment:

Procedure: biceps tenodesis

3

Sham Comparator group

Description:

only a diagnostic arthroscopy performed

Treatment:

Procedure: diagnostic arthroscopy