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

May 29, 2024 updated by: NYU Langone Health
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Reverse Popeye Deformity
Time Frame: up to 24 months post-op
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale
Time Frame: 6 months post-op, 24 months post-op
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)
Time Frame: 6 months post-op, 24 months post-op
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
Time Frame: up to 24 months post-op
up to 24 months post-op
Average timing of return to work/sport
Time Frame: up to 24 months post-op
up to 24 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laith Jazrawi, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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