Superior Labral Tear From Anterior to Posterior (SLAP) Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder

SLAP Tear Clinical Trial

— SLAP  

Official title:

SLAP Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder: A Randomized Outcomes Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02296554
• Other study ID #: 1401M47421
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2018
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Primary isolated SLAP tear, confirmed on MRI

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Shoulder Injuries
• SLAP Tear

Intervention

Procedure:
• SLAP Repair
SLAP repair for SLAP tear
• Biceps Tenodesis
Biceps tenodesis for SLAP tear

Locations

Country	Name	City	State
United States	TRIA Orthopaedic Center	Bloomington	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported function and pain	American Shoulder and Elbow Surgeons (ASES)	Baseline
Primary	Patient reported function and pain	ASES	6 months
Primary	Patient reported function and pain	ASES	1 year
Primary	Patient reported function and pain	ASES	2 years
Primary	Patient reported function and pain	ASES	5 years
Secondary	Range of Motion & Strength	Shoulder/elbow range of motion and strength measurements	Baseline
Secondary	Range of Motion	Shoulder/elbow range of motion	3 months
Secondary	Range of Motion & Strength	Shoulder/elbow range of motion and strength measurements	6 months
Secondary	Range of Motion & Strength	Shoulder/elbow range of motion and strength measurements	1 year
Secondary	Range of Motion & Strength	Shoulder/elbow range of motion and strength measurements	2 years