Study Stopped
Low enrollment
Superior Labral Tear From Anterior to Posterior (SLAP) Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder
SLAP
SLAP Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder: A Randomized Outcomes Study
1 other identifier
interventional
150
1 country
1
Brief Summary
Biceps Tenodesis is currently advocated for older, less active patients, but to date is not often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young, active patients. The ideal surgical management for this pathology is not clearly known. More surgeons are using biceps tenodesis as a treatment for SLAP tears, including in the young, active population. If this study were to demonstrate that biceps tenodesis is similar to or better than SLAP repair, this would fundamentally change the treatment of SLAP tears. Perhaps more importantly, it would likely mean a less involved rehabilitation and earlier return to activities for patients with this pathology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedOctober 30, 2019
November 1, 2018
4.6 years
November 10, 2014
October 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Patient reported function and pain
American Shoulder and Elbow Surgeons (ASES)
Baseline
Patient reported function and pain
ASES
6 months
Patient reported function and pain
ASES
1 year
Patient reported function and pain
ASES
2 years
Patient reported function and pain
ASES
5 years
Secondary Outcomes (5)
Range of Motion & Strength
Baseline
Range of Motion
3 months
Range of Motion & Strength
6 months
Range of Motion & Strength
1 year
Range of Motion & Strength
2 years
Study Arms (2)
SLAP Repair
EXPERIMENTALPatient will receive SLAP repair for their SLAP tear.
Biceps Tenodesis Repair
EXPERIMENTALPatient will receive biceps tenodesis repair for their SLAP tear.
Interventions
Eligibility Criteria
You may qualify if:
- \- Primary isolated SLAP tear, confirmed on MRI
You may not qualify if:
- Concomitant procedure needed such as a labral repair, rotator cuff repair or distal clavicle excision.
- Revision Surgery
- Previous shoulder surgery
- Major medical illness
- Inability to speak or read English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HealthPartners Institutelead
- University of Minnesotacollaborator
Study Sites (1)
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2014
First Posted
November 20, 2014
Study Start
June 1, 2014
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
October 30, 2019
Record last verified: 2018-11