Tenodesis vs. Self-locking Tenotomy in Long Head of the Biceps Tendon Lesions: A Randomized Clinical Trial

NCT ID: NCT04468906

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-05-29

Brief Summary

One of the common complaints after long head of the biceps brachii tendon (LHBT) surgery is a Popeye deformity, which can occur with both the tenodesis and tenotomy. Tenotomy using the traditional technique has a higher incidence of Popeye deformity as the residual stump is not fixated in place. However, the more recently-described self-locking tenotomy improves upon this by having a wider stump base to theoretically prevent reduce the incidence of tendon retraction down the bicipital groove. If this technique is shown to result in a similar incidence of Popeye deformity, then it may be preferable to tenodesis due to its advantages of reduced postoperative pain, more rapid return to activity, and reduced surgical time and cost. The purpose of the proposed study is to evaluate the effect of biceps tenodesis versus self-locking T tenotomy in the management of lesions involving the LHBT.

Detailed Description

Long head of the biceps brachii tendon (LHBT) lesions are a common pathology and can be a significant source of pain in the shoulder due to the large number of free nerve endings around the tendon. There are 3 main subtypes of LHBT lesions 1) LHBT degeneration, 2) LHBT anchor disorders, and 3) LHBT instability. These lesions can occur both in isolation or in conjunction with rotator cuff disease. Treatment options include tenotomy and tenodesis, and while both are utilized there exists a lack of consensus treatment choice.

The optimal management of LHBT lesions remains controversial, with surgeons typically treating younger patients with tenodesis and older patients with tenotomy. Previous RCTs have failed to discern a clinical difference between tenodesis and tenotomy, apart from the reduced incidence of Popeye deformity in the tenodesis cohorts. However, all previous literature has utilized the traditional biceps tenotomy technique of transecting the tendon just lateral to its insertion on the superior labrum. This results in a narrow tendon stump that usually slips through the transverse humeral ligament and retracts down the arm, resulting in the aforementioned deformity. A newer tenotomy technique, termed the self-locking tenotomy, consists of preserving the attachment of the LHBT on the superior labrum and instead releasing the superior labrum off the glenoid from the 11 o'clock to 1 o'clock positions. As a result, the residual LHBT stump is broad and "T-shaped", which has a lower incidence of retracting down the arm. Using this technique, LHBT tenotomy has been shown to result in similar rates of Popeye deformity as the tenodesis in a number of recent case series.

This will be a single-center randomized controlled trial. The study is comparing biceps tenodesis and self-locking tenotomy in patients undergoing arthroscopic shoulder surgery for lesions involving the LHBT.

Conditions

Tenodesis; Tenotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biceps self-locking "T" tenotomy

Group Type: EXPERIMENTAL

Self-locking "T" Tenotomy

Intervention Type: PROCEDURE

Self-locking "T" Tenotomy describes the surgical procedure that will be performed to treat LHBT lesions.

Biceps tenodesis (control)

Group Type: ACTIVE_COMPARATOR

Biceps Tenodesis

Intervention Type: PROCEDURE

Biceps tenodesis describes the surgical procedure that will be performed to treat LHBT lesions.

Interventions

Biceps Tenodesis

Biceps tenodesis describes the surgical procedure that will be performed to treat LHBT lesions.

Intervention Type: PROCEDURE

Self-locking "T" Tenotomy

Self-locking "T" Tenotomy describes the surgical procedure that will be performed to treat LHBT lesions.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Primary indication is for pathology of the LHBT or biceps-labrum complex
• Age 40-80
• Ability to comply with a standardized postoperative protocol
• Willing and able to provide consent

Exclusion Criteria

• Associated rotator cuff tear requiring arthroscopic repair
• Pregnant patient
• Age <40 years
• Previous shoulder surgery
• Unable to speak English or perform informed consent

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laith Jazrawi, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

20-01026

Identifier Type: -

Identifier Source: org_study_id