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Trial record 2 of 112 for:    tendon | Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

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

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ClinicalTrials.gov Identifier: NCT03529162
Recruitment Status : Not yet recruiting
First Posted : May 18, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Kim MD, BSc, St. Louis University

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.

Condition or disease Intervention/treatment Phase
Bicep Tendinitis Biceps; Tenosynovitis Biceps Tendon Disorder Procedure: Long head of Biceps Tenodesis Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529162


Contacts
Contact: Christopher Kim, MD 314-577-8850 christopher.kim@health.slu.edu
Contact: Scott Kaar, MD 314-577-8850 scott.kaar@health.slu.edu

Sponsors and Collaborators
St. Louis University
Investigators
Principal Investigator: Christopher Kim, MD St. Louis University

Publications:
Zehnder Sw, Kaar SG, Joy E. Transpectoral Biceps Sling Tenodesis: Surgical Technique. Tech Should Surg. 2011;12: 32-35.

Responsible Party: Christopher Kim MD, BSc, Principal Investigator, St. Louis University
ClinicalTrials.gov Identifier: NCT03529162     History of Changes
Other Study ID Numbers: 29091
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Christopher Kim MD, BSc, St. Louis University:
Biceps Tendinitis
Subpectoral biceps tenodesis
Biceps tendon disorder

Additional relevant MeSH terms:
Tendinopathy
Tenosynovitis
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries