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

May 24, 2016 updated by: Lovisenberg Diakonale Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0789
        • Lovisenberg Diakonale Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Labral repair with suture anchors
Procedure: labral repair
labral repair with suture anchors
Other Names:
  • lupine anchor
Active Comparator: 2
Biceps tenodesis with suture anchor
Procedure: biceps tenodesis
biceps tenodesis with suture anchor
Other Names:
  • suture anchor
Sham Comparator: 3
only a diagnostic arthroscopy performed
Procedure: diagnostic arthroscopy
diagnostic arthroscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lovisenberg Diakonale Hospital

Investigators

  • Principal Investigator: cecilie p schrøder, MD, Lovisenberg Diakonale Hospital
  • Study Chair: Jens i Brox, MD, PhD, University of Oslo, Rikshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 3, 2008

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

May 25, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00001870

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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