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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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 14, 2014
Last verified: January 2014

December 21, 2007
January 14, 2014
January 2008
January 2014   (final data collection date for primary outcome measure)
WOSI score Constant score EQ-5D Rowe score Patient Satisfaction [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00586742 on ClinicalTrials.gov Archive Site
Sick leave Time back to sports at preoperative level [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study

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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
SLAP Lesions
  • Procedure: labral repair
    labral repair with suture anchors
    Other Name: lupine anchor
  • Procedure: biceps tenodesis
    biceps tenodesis with suture anchor
    Other Name: suture anchor
  • Procedure: diagnostic arthroscopy
    diagnostic arthroscopy
    Other Name: diagnostic arthroscopy
  • Active Comparator: 1
    Labral repair with suture anchors
    Intervention: Procedure: labral repair
  • Active Comparator: 2
    Biceps tenodesis with suture anchor
    Intervention: Procedure: biceps tenodesis
  • Sham Comparator: 3
    only a diagnostic arthroscopy performed
    Intervention: Procedure: diagnostic arthroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
January 2016
January 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact: cecilie p schrøder, MD +47 23226368 cecilie.schroder@ds.no
Contact: øystein skare, Phys-ed +4723226390 oystein.skare@lds.no
Norway
 
NCT00586742
IRB00001870, IRB00001870(REK)
No
Lovisenberg Diakonale Hospital
Lovisenberg Diakonale Hospital
Not Provided
Principal Investigator: cecilie p schrøder, MD Lovisenberg Deaconal hospital
Study Chair: Jens i Brox, MD, PhD University of Oslo, Rikshospitalet
Lovisenberg Diakonale Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP