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

S

Saint Louis University (SLU)

Status

Terminated

Conditions

Biceps Tendon Disorder
Bicep Tendinitis
Biceps; Tenosynovitis

Treatments

Procedure: Long head of Biceps Tenodesis

Study type

Interventional

Funder types

Other

Identifiers

NCT03529162
29091

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4 participants in 2 patient groups

Suture Anchor Technique (SA)
Active Comparator group
Description:
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.
Treatment:
Procedure: Long head of Biceps Tenodesis
Pectoralis Major Technique (PMT)
Active Comparator group
Description:
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.
Treatment:
Procedure: Long head of Biceps Tenodesis

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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