NCT02107586

Brief Summary

The purpose of the study is to determine what the different outcomes are for biceps tenodesis and tenotomy in the treatment of the long head of the biceps pathology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

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 13, 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
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2014

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

April 4, 2014

Last Update Submit

April 24, 2023

Conditions

Chronic Refractive Bicipital Pain

Keywords

biceps tenodesisbiceps tenotomybiceps tendonitisbiceps inflammationshoulder surgery

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 EQ-5D

    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

Biceps tenotomy

ACTIVE COMPARATOR

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

Procedure: Biceps tenotomy

Interventions

Biceps tenotomyPROCEDURE

A biceps tenotomy procedure involves cutting of the long head of the biceps just prior to its insertion on the superior labrum of the glenoid.

Biceps tenotomy
Biceps tenodesisPROCEDURE

Biceps tenodesis involves detaching the long head of the biceps from it's superior labrum in the shoulder and reattaching it to the humerus bone just below the shoulder.

Biceps tenodesis

Eligibility Criteria

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

You may qualify if:

  • patient with chronic refractive bicipital pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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 13, 2013

Primary Completion

April 8, 2014

Study Completion

April 8, 2014

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)