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

Not Applicable

Terminated

• Conditions: Biceps; Tenosynovitis; Bicep Tendinitis; Biceps Tendon Disorder
• Interventions: Procedure: Long head of Biceps Tenodesis

• Registration Number: NCT03529162
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-18
• Study Start: 2018-10-19
• Primary Completion: 2020-01-27
• Study Completion: 2020-01-27
• Results First Submitted: 2021-01-27
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Results First Posted: 2021-04-29
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture Anchor Technique (SA)	Long head of Biceps Tenodesis	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.
Pectoralis Major Technique (PMT)	Long head of Biceps Tenodesis	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.

Primary Outcome Measures

Name	Time	Method
Change in Long Head of the Biceps Tendon Score (LHB)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Visual Analogue Scale (VAS)	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.
Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH)	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.
Change in Single Assessment Numeric Evaluation (SANE)	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.
Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score	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.

Trial Locations

Locations (3)

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

SSM Health - Saint Louis University Hospital; 🇺🇸 Saint Louis, Missouri, United States

SSM Health - St. Mary's Hospital; 🇺🇸 Saint Louis, Missouri, United States