NCT02107547

Brief Summary

The purpose of the study is to determine which of the two alternative surgical interventions (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior Labrum Anterior and Posterior lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2017

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

3.9 years

First QC Date

April 4, 2014

Last Update Submit

April 24, 2023

Conditions

Type 2 SLAP Lesions

Keywords

Randomized Controlled Trial (RCT)Type 2 SLAP lesionslabral tearbiceps tenodesisshoulder surgeryRCTComparison between two alternative surgical procedures

Outcome Measures

Primary Outcomes (1)

  • American Shoulder and Elbow Surgeons (ASES) Shoulder Score

    The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.

    one year

Secondary Outcomes (1)

  • EuroQol five dimensions

    one year

Study Arms (2)

Biceps tenodesis

ACTIVE COMPARATOR

32 subjects in the study will receive biceps tenodesis as a surgical intervention

Procedure: Biceps tenodesis

Labral repair

ACTIVE COMPARATOR

32 subjects in the study will receive labral repair as a surgical intervention

Procedure: Labral repair

Interventions

Biceps tenodesisPROCEDURE

A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm.

Biceps tenodesis
Labral repairPROCEDURE

Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum.

Labral repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with MRI diagnosed Superior Labrum Anterior and Posterior 2 lesion

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Study Officials

  • Lewis L Shi, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 8, 2014

Study Start

May 23, 2013

Primary Completion

April 11, 2017

Study Completion

April 11, 2017

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)