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

NCT04468906 | Terminated DMC

• 1 other identifier: 20-01026
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Tenodesis; Tenotomy

Keywords

LHBT

Outcome Measures

Primary Outcomes (1)

• Rate of Reverse Popeye Deformity

  Reverse popeye deformity is the loss of the theoretical LHBT stabilizing effect on the humeral head, which can be determined with a physical exam.

  up to 24 months post-op

Secondary Outcomes (4)

• Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale

  6 months post-op, 24 months post-op

• Change in Score on Visual Analogue Scale (VAS)

  6 months post-op, 24 months post-op

• Incidence of fatigue, cramping, biceps groove tenderness

  up to 24 months post-op

• Average timing of return to work/sport

  up to 24 months post-op

Study Arms (2)

Biceps self-locking "T" tenotomy

EXPERIMENTAL

Procedure: Self-locking "T" Tenotomy

Biceps tenodesis (control)

ACTIVE COMPARATOR

Procedure: Biceps Tenodesis

Interventions

Biceps Tenodesis PROCEDURE

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

Biceps tenodesis (control)

Self-locking "T" Tenotomy PROCEDURE

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

Biceps self-locking "T" tenotomy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Laith Jazrawi, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 13, 2020
• Study Start: September 1, 2020
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to use the data upon reasonable request. Requests should be directed to laith.jazrawi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)