A Prospective Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis

April 27, 2021 updated by: Howard M Place, St. Louis University

A Prospective Randomized Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis

This is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis currently exist and are commonly performed. We will be comparing the tenodesis procedure using a suture anchor device versus a technique where the tendon is simply sutured to the pectoralis major tendon.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Biceps tenodesis is a commonly performed procedure in shoulder surgery. In many cases, it is performed in conjunction with a rotator cuff repair. Currently, biceps tenodesis is performed in many different ways depending on surgeon preference. First, the location of the tenodesis can vary, as surgeons may prefer a suprapectoral or subpectoral tenodesis location. In addition, the tenodesis fixation technique can also vary, as surgeons have the option to use a screw or suture anchor to perform the tenodesis. There have been numerous studies comparing these various techniques, including suprapectoral versus subpectoral techniques and screw versus suture anchor techniques. None of these studies have been conclusive, and there continues to be controversy as to the best technique.

The current study will compare two techniques of subpectoral biceps tenodesis. Specifically, we will compare tenodesis using a suture anchor versus a technique where the tendon is simply sutured to the pectoralis major tendon. The latter technique has been previously described and published.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
      • Saint Louis, Missouri, United States, 63110
        • SSM Health - Saint Louis University Hospital
      • Saint Louis, Missouri, United States, 63110
        • SSM Health - St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 - 100 years
  • Able to provide written informed consent
  • Has: (a) partial- or full-thickness rotator cuff tear verified by preoperative magnetic resonance imaging (MRI) and arthroscopy; (b) concomitant biceps lesions (LHBT partial tear>50%, SLAP type II lesion, pulley lesion, or subluxation/dislocation of LHBT) that were diagnosed arthroscopically with concomitant symptoms; and (c) arthroscopic rotator cuff repair.

Exclusion Criteria:

  • Any medical illness that adversely impacts the patient's ability to complete the study procedures
  • Isolated glenohumeral pathological conditions
  • Any prior surgery on the same shoulder
  • Complete rupture of the LHBT assessed by MRI or at time of procedure
  • Incomplete repair of the rotator cuff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Suture Anchor Technique (SA)
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.
Procedure: Long head of Biceps Tenodesis
Patients will be randomized into two different groups to compare biceps tenodesis techniques
Active Comparator: Pectoralis Major Technique (PMT)
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.
Procedure: Long head of Biceps Tenodesis
Patients will be randomized into two different groups to compare biceps tenodesis techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Long Head of the Biceps Tendon Score (LHB)
Time Frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
The LHB score is a composite endpoint (maximum 100 points) that evaluates 'biceps pain and muscle cramps', 'cosmesis', and 'flexion strength at the elbow'. It is an outcome score specific for biceps tendon pathology. The score range is 0-100, with a higher score representing better function. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale (VAS)
Time Frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. "0" is no pain and "10" is the worst pain. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Time Frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Change in Single Assessment Numeric Evaluation (SANE)
Time Frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure (PROM). Scoring is 1 to 100, with 100 being the highest function/no pain score. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time Frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.

The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology regardless of their specific diagnosis.

The ASES score contains a physician-rated and patient-rated section; however, only the pain visual analog scale (VAS) and 10 functional questions are typically used to tabulate the reported ASES score. The total score - 100 maximum points - is weighted 50% for pain and 50% for function. A score of 100 represents a better outcome and a score of 0 represents a worse outcome. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Investigators

  • Principal Investigator: Christopher Kim, MD, St. Louis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2018

Primary Completion (Actual)

January 27, 2020

Study Completion (Actual)

January 27, 2020

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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