Back to resultsAnalysis of Suprapectoral and Subpectoral Biceps Tenodesis
Primary Purpose
Biceps Tendonitis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suprapectoral Biceps tenodesis
Subpectoral biceps tenodesis
Sponsored by
About this trial
This is an interventional treatment trial for Biceps Tendonitis
Eligibility Criteria
Inclusion Criteria:
- Scheduled to undergo biceps tenodesis
- Pain at intertubercular groove
- Anterior Humeral pain
- Patient agrees to follow up and consent
Exclusion Criteria:
- Biceps Tenotomy
- Revision biceps procedure
- Prior SLAP or labral repair
- Concomitant subscapularis repair
- More than 1 rotator cuff repair at time of surgery
- Concomitant arthroplasty
- Prior infection
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Suprapectoral Biceps Tenodesis
Subpectoral Biceps Tenodesis
Arm Description
Suprapectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the superior border of the pectoralis major insertion
Subpectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the inferior border of the pectoralis major insertion
Outcomes
Primary Outcome Measures
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Validated outcome score assessing pain and function of shoulder
Secondary Outcome Measures
Constant Score
Validated score to assess shoulder pain and function
Full Information
NCT ID
NCT02192073
First Posted
May 21, 2014
Last Updated
September 8, 2021
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02192073
Brief Title
Analysis of Suprapectoral and Subpectoral Biceps Tenodesis
Official Title
Prospective Analysis of Arthroscopic Suprapectoral and Open Subpectoral Biceps Tenodesis: 1 Year Follow-Up
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Biceps pathology typically includes pain in the anterior shoulder that is reproduced with provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in the shoulder).
Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open subpectoral biceps tenodesis results in better function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biceps Tendonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suprapectoral Biceps Tenodesis
Arm Type
Active Comparator
Arm Description
Suprapectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the superior border of the pectoralis major insertion
Arm Title
Subpectoral Biceps Tenodesis
Arm Type
Active Comparator
Arm Description
Subpectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the inferior border of the pectoralis major insertion
Intervention Type
Procedure
Intervention Name(s)
Suprapectoral Biceps tenodesis
Intervention Type
Procedure
Intervention Name(s)
Subpectoral biceps tenodesis
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Description
Validated outcome score assessing pain and function of shoulder
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Constant Score
Description
Validated score to assess shoulder pain and function
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled to undergo biceps tenodesis
Pain at intertubercular groove
Anterior Humeral pain
Patient agrees to follow up and consent
Exclusion Criteria:
Biceps Tenotomy
Revision biceps procedure
Prior SLAP or labral repair
Concomitant subscapularis repair
More than 1 rotator cuff repair at time of surgery
Concomitant arthroplasty
Prior infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil N Verma, MD
Organizational Affiliation
Rush Univeristy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35507468
Citation
Forsythe B, Berlinberg EJ, Diaz CC, Korrapati A, Agarwalla A, Patel HH, Cole BJ, Cvetanovich GL, Yanke AB, Romeo AA, Verma NN. No Difference in Clinical Outcomes for Arthroscopic Suprapectoral Versus Open Subpectoral Biceps Tenodesis at Midterm Follow-up: A Randomized Prospective Analysis. Am J Sports Med. 2022 May;50(6):1486-1494. doi: 10.1177/03635465221084731.
Results Reference
derived
Learn more about this trial
Analysis of Suprapectoral and Subpectoral Biceps Tenodesis
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