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

SLAP Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586742
• Other study ID #: IRB00001870
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: May 24, 2016
• Start date: January 2008
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Lovisenberg Diakonale Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• SLAP Lesions

Intervention

Procedure:
• labral repair
labral repair with suture anchors
• biceps tenodesis
biceps tenodesis with suture anchor
• diagnostic arthroscopy
diagnostic arthroscopy

Locations

Country	Name	City	State
Norway	Lovisenberg Diakonale Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOSI score Constant score EQ-5D Rowe score Patient Satisfaction		6 and 24 months	No
Secondary	Sick leave Time back to sports at preoperative level		6 and 24 months	No