Simple Biceps TenotomyNCT06833398
Comparison Between Arthroscopic Simple Biceps Tenotomy & Anchor Technique Tenotomy with Clinical and Ultrasound Assessment
A study testing Arthroscopic Simple Biceps Tenotomy: and Anchor Tenotomy Technique: in people with Simple Biceps Tenotomy and Anchor Tenotomy, run by Assiut University at 1 site in Egypt.
Trial summary
Comparison between arthroscopic simple biceps tenotomy \& anchor tenotomy technique regarding clinical outcomes \& ultrasound assessment Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Simple Biceps Tenotomy, Anchor Tenotomy
- What is being tested?
- Arthroscopic Simple Biceps Tenotomy: and Anchor Tenotomy Technique:
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with LHB pathologies such as :
- Biceps tendinitis Rotator cuff tears Subacromial impengiment Instability \& traumatic causes
Who cannot join
- LHB Tenodesis Patients with neuromuscular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut
Amany Omar, Vice dean of graduate studies, +2088 22080150 ext. +20, vp_grad@aun.edu.eg
About this study
Official title: Arthroscopic Simple Biceps Tenotomy Versus Anchor Tenotomy Technique, Clinical Outcome and Ultrasound Assessment
Comparison between arthroscopic simple biceps tenotomy \& anchor tenotomy technique regarding clinical outcomes \& ultrasound assessment
Read the detailed description
This research compares two surgical techniques for addressing pathologies of the long head of the biceps (LHB) tendon: arthroscopic simple biceps tenotomy and anchor tenotomy. The LHB tendon, originating from the supraglenoid tubercle, plays a critical role in forearm supination, elbow flexion, and shoulder abduction. Pathologies affecting this tendon often cause significant shoulder pain, with surgical options including tenotomy and tenodesis. While simple tenotomy is quick and avoids implant complications, it may result in cosmetic deformities like the "Popeye" sign and muscle cramps. Anchor tenotomy, a novel technique, aims to minimize these issues by preventing the Popeye deformity. This study employs a prospective randomized double-blinded controlled trial design at Assiut University Hospitals, involving 72 patients with LHB pathologies such as tendinitis, rotator cuff tears, and subacromial impingement. Exclusion criteria include prior tenodesis or neuromuscular diseases. Clinical outcomes will be assessed using functional scores (e.g., Oxford Shoulder Score), ultrasound evaluation of tendon positioning, and follow-up examinations at intervals up to one year post-surgery. The primary outcome focuses on the presence of the Popeye deformity, while secondary outcomes include postoperative shoulder function and tendon distalization measured via ultrasound. This research aims to provide evidence-based insights into the comparative effectiveness of these two techniques in improving clinical outcomes and minimizing complications.
- Conditions
- Simple Biceps Tenotomy, Anchor Tenotomy
- Being tested
- Arthroscopic Simple Biceps Tenotomy:, Anchor Tenotomy Technique:
- Keywords
- Arthroscopic biceps tenotomy, Long head of biceps tendon (LHB) Popeye deformity Ultrasound assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Simple Biceps Tenotomy:Procedure or surgery
Arthroscopic Simple Biceps Tenotomy: This procedure involves an arthroscopic release of the LHB tendon from its attachment at the superior glenoid labrum. It is a quick and simple technique that does not require implants or extensive postoperative rehabilitation. The main drawback is the potential for developing a "Popeye" deformity, where the biceps muscle bulges due to distal migration, as well as occasional muscle cramps.
Anchor Tenotomy Technique:Procedure or surgery
Anchor Tenotomy Technique: This is a novel arthroscopic method where, after releasing the LHB tendon, it is anchored in place to prevent distal migration. The goal of this technique is to avoid the Popeye deformity and improve cosmetic outcomes while maintaining functional integrity. This procedure is technically more challenging and may involve a longer operative time compared to simple tenotomy.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic simple Biceps tenotomy | Experimental | This group undergoes a straightforward arthroscopic procedure to release the LHB tendon. The technique is quick and avoids the need for implants or prolonged rehabilitation. However, it carries a risk of cosmetic deformities, such as the "Popeye" sign, and potential biceps muscle cramps postoperatively. |
| anchor tenotomy technique | Experimental | This group undergoes a novel anchor-based tenotomy technique. The procedure aims to prevent the Popeye deformity by anchoring the released tendon in a specific position. While technically more complex than simple tenotomy, it is designed to improve cosmetic outcomes and potentially reduce postoperative complications. Receives: Procedure: Anchor Tenotomy Technique: |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate for popeye sign after arthroscopic simple biceps tenotomy vs anchor technique tenotomy
clinical evaluation of shoulder function postoperative by dynamometer \& US assessment of LHB tendon distalization after LHB tenotomy .
Remove
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start30 Jun 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simple Biceps TenotomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sayed Shehata, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833398
- Sponsor's protocol ID
- biceps tenotomy technique
- Status last verified
- Dec 2024
- First submitted
- 13 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Simple Biceps Tenotomy Versus Anchor Tenotomy Technique, Clinical Outcome and Ultrasound Assessment
- ClinicalTrials.gov ID
- NCT06833398
- Acronym / sponsor ID
- biceps tenotomy technique
- Conditions
- Simple Biceps Tenotomy, Anchor Tenotomy
- Keywords
- Arthroscopic biceps tenotomy, Long head of biceps tendon (LHB) Popeye deformity Ultrasound assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between arthroscopic simple biceps tenotomy \& anchor tenotomy technique regarding clinical outcomes \& ultrasound assessment
Detailed description
This research compares two surgical techniques for addressing pathologies of the long head of the biceps (LHB) tendon: arthroscopic simple biceps tenotomy and anchor tenotomy. The LHB tendon, originating from the supraglenoid tubercle, plays a critical role in forearm supination, elbow flexion, and shoulder abduction. Pathologies affecting this tendon often cause significant shoulder pain, with surgical options including tenotomy and tenodesis. While simple tenotomy is quick and avoids implant complications, it may result in cosmetic deformities like the "Popeye" sign and muscle cramps. Anchor tenotomy, a novel technique, aims to minimize these issues by preventing the Popeye deformity. This study employs a prospective randomized double-blinded controlled trial design at Assiut University Hospitals, involving 72 patients with LHB pathologies such as tendinitis, rotator cuff tears, and subacromial impingement. Exclusion criteria include prior tenodesis or neuromuscular diseases. Clinical outcomes will be assessed using functional scores (e.g., Oxford Shoulder Score), ultrasound evaluation of tendon positioning, and follow-up examinations at intervals up to one year post-surgery. The primary outcome focuses on the presence of the Popeye deformity, while secondary outcomes include postoperative shoulder function and tendon distalization measured via ultrasound. This research aims to provide evidence-based insights into the comparative effectiveness of these two techniques in improving clinical outcomes and minimizing complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic simple Biceps tenotomy | Experimental | –This group undergoes a straightforward arthroscopic procedure to release the LHB tendon. The technique is quick and avoids the need for implants or prolonged rehabilitation. However, it carries a risk of cosmetic deformities, such as the "Popeye" sign, and potential biceps muscle cramps postoperatively. |
| anchor tenotomy technique | Experimental | Procedure: Anchor Tenotomy Technique:This group undergoes a novel anchor-based tenotomy technique. The procedure aims to prevent the Popeye deformity by anchoring the released tendon in a specific position. While technically more complex than simple tenotomy, it is designed to improve cosmetic outcomes and potentially reduce postoperative complications. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with LHB pathologies such as :
- Biceps tendinitis Rotator cuff tears Subacromial impengiment Instability \& traumatic causes
Key exclusion criteria (1 listed)
- LHB Tenodesis Patients with neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic Simple Biceps Tenotomy:Arthroscopic Simple Biceps Tenotomy: This procedure involves an arthroscopic release of the LHB tendon from its attachment at the superior glenoid labrum. It is a quick and simple technique that does not require implants or extensive postoperative rehabilitation. The main drawback is the potential for developing a "Popeye" deformity, where the biceps muscle bulges due to distal migration, as well as occasional muscle cramps. | Procedure or surgery | – |
| Anchor Tenotomy Technique:Anchor Tenotomy Technique: This is a novel arthroscopic method where, after releasing the LHB tendon, it is anchored in place to prevent distal migration. The goal of this technique is to avoid the Popeye deformity and improve cosmetic outcomes while maintaining functional integrity. This procedure is technically more challenging and may involve a longer operative time compared to simple tenotomy. | Procedure or surgery | anchor tenotomy technique |
Primary outcome
evaluate for popeye sign after arthroscopic simple biceps tenotomy vs anchor technique tenotomy
Time frame: 1 year
clinical evaluation of shoulder function postoperative by dynamometer \& US assessment of LHB tendon distalization after LHB tenotomy . Remove
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Simple Biceps Tenotomy: and Anchor Tenotomy Technique: in people with Simple Biceps Tenotomy and Anchor Tenotomy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed S shehata, bachelor of medicine (01010527046, Ahmed.15248388@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate for popeye sign after arthroscopic simple biceps tenotomy vs anchor technique tenotomy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.