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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00586742
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Lovisenberg Diakonale Hospital

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE January 4, 2008
Last Update Posted Date May 25, 2016
Study Start Date  ICMJE January 2008
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
WOSI score Constant score EQ-5D Rowe score Patient Satisfaction [ Time Frame: 6 and 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
Sick leave Time back to sports at preoperative level [ Time Frame: 6 and 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
Official Title  ICMJE SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE SLAP Lesions
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2016)
118
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2008)
120
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00586742
Other Study ID Numbers  ICMJE IRB00001870
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lovisenberg Diakonale Hospital
Study Sponsor  ICMJE Lovisenberg Diakonale Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: cecilie p schrøder, MD Lovisenberg Diakonale Hospital
Study Chair: Jens i Brox, MD, PhD University of Oslo, Rikshospitalet
PRS Account Lovisenberg Diakonale Hospital
Verification Date May 2016

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