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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529162
Recruitment Status : Terminated (COVID-19, followed by PI leaving institution.)
First Posted : May 18, 2018
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Howard Place, MD, St. Louis University

Tracking Information
First Submitted Date  ICMJE April 23, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date August 21, 2020
Actual Study Start Date  ICMJE October 19, 2018
Actual Primary Completion Date January 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
Change in Long Head of the Biceps Score (LHB) [ Time Frame: This score will be obtained pre-operatively, and post-operatively at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
  • Change in Visual Analogue Scale (VAS) [ Time Frame: This score will be obtained pre-operatively, and post-operatively at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months. ]
    A continuous scale composed of a straight line with the endpoints ranging from no pain to extreme pain, where the patient can visually assess and mark their level of pain.
  • Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH) [ Time Frame: This score will be obtained pre-operatively, and post-operatively at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months. ]
    The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to indicate the impact of an impairment on the level and type of disability.
  • Change in Single Assessment Numeric Evaluation (SANE) [ Time Frame: This score will be obtained pre-operatively, and post-operatively at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months. ]
    A numeric score where the patient is simply asked to rate their shoulder function on a scale from 0-100. This is a commonly utilized score for shoulder surgery patients
  • Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score [ Time Frame: This score will be obtained pre-operatively, and post-operatively at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months. ]
    A 100-point score used to assess level of pain and function in the shoulder patient
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis
Official Title  ICMJE A Prospective Randomized Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bicep Tendinitis
  • Biceps; Tenosynovitis
  • Biceps Tendon Disorder
Intervention  ICMJE Procedure: Long head of Biceps Tenodesis
Patients will be randomized into two different groups to compare biceps tenodesis techniques
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Long head of Biceps Tenodesis
  • 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.
    Intervention: Procedure: Long head of Biceps Tenodesis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 19, 2020)
4
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2018)
80
Actual Study Completion Date  ICMJE January 27, 2020
Actual Primary Completion Date January 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529162
Other Study ID Numbers  ICMJE 29091
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Howard Place, MD, St. Louis University
Study Sponsor  ICMJE St. Louis University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Kim, MD St. Louis University
PRS Account St. Louis University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP