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

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.

Study Overview

• Status: Terminated
• Conditions: Tenodesis; Tenotomy
• Intervention / Treatment: Procedure: Self-locking "T" Tenotomy; Procedure: Biceps Tenodesis

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biceps self-locking "T" tenotomy	Procedure: Self-locking "T" Tenotomy; Self-locking "T" Tenotomy describes the surgical procedure that will be performed to treat LHBT lesions.
Active Comparator: Biceps tenodesis (control)	Procedure: Biceps Tenodesis; Biceps tenodesis describes the surgical procedure that will be performed to treat LHBT lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale	The ASES scale consists of two subscales: pain (0-50 points) and function/disability (0-50 points), with a total score range of 0-100 points. The lower the score, the greater the pain and disability.	6 months post-op, 24 months post-op
Change in Score on Visual Analogue Scale (VAS)	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain possible." The total score range is 0-10. The higher the score, the higher the pain level experienced.	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Laith Jazrawi, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): May 29, 2024
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: LHBT
• Other Study ID Numbers: 20-01026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No