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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SLAP Lesions | Procedure: labral repair Procedure: biceps tenodesis Procedure: diagnostic arthroscopy | Not Applicable |
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
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Procedure: labral repair
labral repair with suture anchors
Other Name: lupine anchor |
Active Comparator: 2
Biceps tenodesis with suture anchor
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Procedure: biceps tenodesis
biceps tenodesis with suture anchor
Other Name: suture anchor |
Sham Comparator: 3
only a diagnostic arthroscopy performed
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Procedure: diagnostic arthroscopy
diagnostic arthroscopy |
- WOSI score Constant score EQ-5D Rowe score Patient Satisfaction [ Time Frame: 6 and 24 months ]
- Sick leave Time back to sports at preoperative level [ Time Frame: 6 and 24 months ]

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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 |
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)

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
Norway | |
Lovisenberg Diakonale Hospital | |
Oslo, Norway, 0789 |
Principal Investigator: | cecilie p schrøder, MD | Lovisenberg Diakonale Hospital | |
Study Chair: | Jens i Brox, MD, PhD | University of Oslo, Rikshospitalet |
Responsible Party: | Lovisenberg Diakonale Hospital |
ClinicalTrials.gov Identifier: | NCT00586742 |
Other Study ID Numbers: |
IRB00001870 |
First Posted: | January 4, 2008 Key Record Dates |
Last Update Posted: | May 25, 2016 |
Last Verified: | May 2016 |
SLAP lesions labral repair bicepstenodesis conservative treatment |