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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00586742
First Posted: January 4, 2008
Last Update Posted: May 25, 2016
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.
Information provided by (Responsible Party):
Lovisenberg Diakonale Hospital
  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 (Participant, Care Provider)
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 ]

Secondary Outcome Measures:
  • Sick leave Time back to sports at preoperative level [ Time Frame: 6 and 24 months ]

Enrollment: 118
Study Start Date: January 2008
Study Completion Date: April 2016
Primary Completion Date: April 2016 (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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586742


Locations
Norway
Lovisenberg Diakonale Hospital
Oslo, Norway, 0789
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
Investigators
Principal Investigator: cecilie p schrøder, MD Lovisenberg Diakonale Hospital
Study Chair: Jens i Brox, MD, PhD University of Oslo, Rikshospitalet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier: NCT00586742     History of Changes
Other Study ID Numbers: IRB00001870
First Submitted: December 21, 2007
First Posted: January 4, 2008
Last Update Posted: May 25, 2016
Last Verified: May 2016

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