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

This study is currently recruiting participants.
Verified January 2012 by Lovisenberg Diakonale Hospital
Sponsor:
Information provided by (Responsible Party):
Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier:
NCT00586742
First received: December 21, 2007
Last updated: January 2, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
SLAP Lesions
 Procedure: labral repair
Procedure: biceps tenodesis
Procedure: diagnostic arthroscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study

Further study details as provided by Lovisenberg Diakonale Hospital:

Primary Outcome Measures:
  • WOSI score Constant score EQ-5D Rowe score Patient Satisfaction [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sick leave Time back to sports at preoperative level [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Labral repair with suture anchors
 Procedure: labral repair
labral repair with suture anchors
Other Name: lupine anchor
Active Comparator: 2
Biceps tenodesis with suture anchor
 Procedure: biceps tenodesis
biceps tenodesis with suture anchor
Other Name: suture anchor
Sham Comparator: 3
only a diagnostic arthroscopy performed
 Procedure: diagnostic arthroscopy
diagnostic arthroscopy
Other Name: diagnostic arthroscopy

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586742

Contacts
Contact: cecilie p schrøder, MD +47 23226368 cecilie.schroder@ds.no
Contact: øystein skare, Phys-ed +4723226390 oystein.skare@lds.no

Locations
Norway
Lovisenberg Deaconal Hospital Recruiting
Oslo, Norway, 0789
Contact: cecilie p schrøder, MD     +4723226368     cecilie.schrøder@lds.no    
Principal Investigator: cecilie p schrøder, MD            
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
Investigators
Principal Investigator: cecilie p schrøder, MD Lovisenberg Deaconal hospital
Study Chair: Jens i Brox, MD, PhD University of Oslo, Rikshospitalet
  More Information

No publications provided

Responsible Party: Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier: NCT00586742     History of Changes
Other Study ID Numbers: IRB00001870, IRB00001870(REK)
Study First Received: December 21, 2007
Last Updated: January 2, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Lovisenberg Diakonale Hospital:
SLAP lesions
labral repair
bicepstenodesis
conservative treatment

ClinicalTrials.gov processed this record on May 19, 2013