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

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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

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.

Condition or disease Intervention/treatment Phase
SLAP Lesions Procedure: labral repair Procedure: biceps tenodesis Procedure: diagnostic arthroscopy Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. WOSI score Constant score EQ-5D Rowe score Patient Satisfaction [ Time Frame: 6 and 24 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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)

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