SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
NCT ID: NCT00586742
Last Updated: 2016-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2008-01-31
2016-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Labral repair with suture anchors
labral repair
labral repair with suture anchors
2
Biceps tenodesis with suture anchor
biceps tenodesis
biceps tenodesis with suture anchor
3
only a diagnostic arthroscopy performed
diagnostic arthroscopy
diagnostic arthroscopy
Interventions
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labral repair
labral repair with suture anchors
biceps tenodesis
biceps tenodesis with suture anchor
diagnostic arthroscopy
diagnostic arthroscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MRI study revealing an isolated superior labral lesion
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Lovisenberg Diakonale Hospital
OTHER
Responsible Party
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Principal Investigators
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cecilie p schrøder, MD
Role: PRINCIPAL_INVESTIGATOR
Lovisenberg Diakonale Hospital
Jens i Brox, MD, PhD
Role: STUDY_CHAIR
University of Oslo, Rikshospitalet
Locations
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Lovisenberg Diakonale Hospital
Oslo, Oslo County, Norway
Countries
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References
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Brox JI, Skare O, Mowinckel P, Brox JS, Reikeras O, Schroder CP. Sick leave and return to work after surgery for type II SLAP lesions of the shoulder: a secondary analysis of a randomised sham-controlled study. BMJ Open. 2020 Apr 1;10(4):e035259. doi: 10.1136/bmjopen-2019-035259.
Schroder CP, Skare O, Reikeras O, Mowinckel P, Brox JI. Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial. Br J Sports Med. 2017 Dec;51(24):1759-1766. doi: 10.1136/bjsports-2016-097098. Epub 2017 May 11.
Skare O, Schroder CP, Reikeras O, Mowinckel P, Brox JI. Efficacy of labral repair, biceps tenodesis, and diagnostic arthroscopy for SLAP lesions of the shoulder: a randomised controlled trial. BMC Musculoskelet Disord. 2010 Oct 7;11:228. doi: 10.1186/1471-2474-11-228.
Other Identifiers
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IRB00001870
Identifier Type: -
Identifier Source: org_study_id
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