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NCT04468906 · ClinicalTrials.gov registry record · NA
Tenodesis vs. Self-locking Tenotomy in Long Head of the Biceps Tendon Lesions: A Randomized Clinical Trial
A NA study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT04468906: Clinical Trial NA study, sponsored by NYU Langone Health.
NCT04468906 is a NA study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04468906, a NA study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
Reverse popeye deformity is the loss of the theoretical LHBT stabilizing effect on the humeral head, which can be determined with a physical exam.
Interventions
- PROCEDURE Biceps Tenodesis
- PROCEDURE Self-locking "T" Tenotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2024-05-29 |
| Phase | NA |
Why NCT04468906 stopped before completion
NCT04468906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Biceps Tenodesis is the first listed.
NCT04468906 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04468906 about?
NCT04468906 is a clinical study titled "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. How...
What is the current status of trial NCT04468906?
This trial is currently terminated. It is a NA study. The enrollment target is 42 participants. The study started on 2020-09-01. Estimated completion is 2024-05-29.
What interventions are being tested in trial NCT04468906?
The interventions under investigation include: Biceps Tenodesis (PROCEDURE), Self-locking "T" Tenotomy (PROCEDURE).
Who is sponsoring clinical trial NCT04468906?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04468906's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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