Bicep TendinitisNCT07014813
Mini-Open Subpectoral Biceps Tenodesis
A study testing Sub pectoral fixation in people with Bicep Tendinitis, run by Cairo University at 1 site in Egypt.
Trial summary
Surgical management of long head of biceps (LHB) lesions is frequent, often alongside other shoulder issues. When conservative treatment fails, tenotomy (for low-demand patients) or tenodesis (preferred for active individuals) is performed. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bicep Tendinitis
- What is being tested?
- Sub pectoral fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Biceps tendon pathologies after failure of conservative measures: biceps tenosynovitis, recurrent subluxation, or SLAP lesions.
- Young and middle-aged individuals (20-60 years old).
Who cannot join
- Patients with avascular necrosis or arthritis.
- Extensive bone loss.
- Poor bone density.
- Active infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mini Open Subpectoral Press Fit Biceps Tenodesis
Surgical management of long head of biceps (LHB) lesions is frequent, often alongside other shoulder issues. When conservative treatment fails, tenotomy (for low-demand patients) or tenodesis (preferred for active individuals) is performed. Subpectoral tenodesis offers advantages, and this study assesses a novel press-fit bony plug technique for this approach, evaluating its safety and efficacy.
- Conditions
- Bicep Tendinitis
- Being tested
- Sub pectoral fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub pectoral fixationProcedure or surgery
Subpectoral biceps tenodesis via mini-open incision. Biceps tendon prepared with Krackow sutures, press-fit into bony tunnel using harvested bone plug. Stability checked post-fixation.
| Study group | Role | What they receive |
|---|---|---|
| Candidate Group | Other | The Candidate Group Patients were 30 patients:
* Seventeen females and Thirteen males with a mean age of 44.4 years (range: 30-60 years).
* Eight patients were smokers, and ten suffered from controlled diabetes.
* Three patients were suffering from isolated biceps tendinopathy without associated pathology, Nine were suffering from frozen shoulder, Fifteen patients with different degrees of rotator cuff tears, and the last three patients had biceps slap lesions which were irreparable with anchors.
* There were 21 dominant and 9 non-dominant shoulders. Receives: Procedure: Sub pectoral fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients reported having at least a 50% Increase in their Amircan Shoulder and Elbow Society (ASES) Scoring, and decrease in their pain (measured according to VAS score) with no loss in the range of motion.
The Success rate of sub-pectoral fixation of the biceps tendon was assessed as that there was proportion of patients who achieved a clinically significant improvement in shoulder and elbow function (at least a 50% increase in ASES score), a notable reduction in pain (decrease in VAS score), while maintaining their ange of motion.
Measured: 42 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jan 2021
- Primary completion15 Apr 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicep TendinitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Abd ElGhafour Abd ElRady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014813
- Sponsor's protocol ID
- RC-1910-2024
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini Open Subpectoral Press Fit Biceps Tenodesis
- ClinicalTrials.gov ID
- NCT07014813
- Acronym / sponsor ID
- RC-1910-2024
- Conditions
- Bicep Tendinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 11 Jun 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.
Surgical management of long head of biceps (LHB) lesions is frequent, often alongside other shoulder issues. When conservative treatment fails, tenotomy (for low-demand patients) or tenodesis (preferred for active individuals) is performed. Subpectoral tenodesis offers advantages, and this study assesses a novel press-fit bony plug technique for this approach, evaluating its safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidate Group | Other | Procedure: Sub pectoral fixationThe Candidate Group Patients were 30 patients: * Seventeen females and Thirteen males with a mean age of 44.4 years (range: 30-60 years). * Eight patients were smokers, and ten suffered from controlled diabetes. * Three patients were suffering from isolated biceps tendinopathy without associated pathology, Nine were suffering from frozen shoulder, Fifteen patients with different degrees of rotator cuff tears, and the last three patients had biceps slap lesions which were irreparable with anchors. * There were 21 dominant and 9 non-dominant shoulders. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with Biceps tendon pathologies after failure of conservative measures: biceps tenosynovitis, recurrent subluxation, or SLAP lesions.
- Young and middle-aged individuals (20-60 years old).
Key exclusion criteria (4 listed)
- Patients with avascular necrosis or arthritis.
- Extensive bone loss.
- Poor bone density.
- Active infection.
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 |
|---|---|---|
| Sub pectoral fixationSubpectoral biceps tenodesis via mini-open incision. Biceps tendon prepared with Krackow sutures, press-fit into bony tunnel using harvested bone plug. Stability checked post-fixation. | Procedure or surgery | Candidate Group |
Primary outcome
The proportion of patients reported having at least a 50% Increase in their Amircan Shoulder and Elbow Society (ASES) Scoring, and decrease in their pain (measured according to VAS score) with no loss in the range of motion.
Time frame: 42 Months
The Success rate of sub-pectoral fixation of the biceps tendon was assessed as that there was proportion of patients who achieved a clinically significant improvement in shoulder and elbow function (at least a 50% increase in ASES score), a notable reduction in pain (decrease in VAS score), while maintaining their ange of motion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub pectoral fixation in people with Bicep Tendinitis, run by Cairo 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 4 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: finished, as of the sponsor's last update on 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients reported having at least a 50% Increase in their Amircan Shoulder and Elbow Society (ASES) Scoring, and decrease in their pain (measured according to VAS score) with no loss in the range of motion. (time frame: 42 Months). 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 11 Jun 2025.