SLAP LesionNCT07113821
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV
A study testing Biceps tenodesis alone and Biceps tenodesis and labrum repair in people with SLAP Lesion, run by Assiut University.
Trial summary
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- SLAP Lesion
- What is being tested?
- Biceps tenodesis alone and Biceps tenodesis and labrum repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2025
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Traumatic and degenerative etiology.
- No shoulder deformity .
- No inflammatory joint disorders.
- Type of the SLAP is SLAP lesion from type II to type IV
Who cannot join
- History of the disease.
- Bilateral shoulder.
- DM .
- Epilepsy .
- psychological disturbance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV
Read the detailed description
A SLAP (Superior Labrum Anterior to Posterior) lesion is a specific type of shoulder injury that involves damage to the superior labrum, which is the cartilage rim around the socket of the shoulder joint. This type of injury typically occurs at the long head of the biceps tendon attaches to the labrum. The patient may feel pain, popping sensations and decreased range of motion in the shoulder.1 SLAP lesions are occurring in younger individuals,who playing sports that require repetitive overhead motions and presenting in individuals who have shoulder trauma injury,such as a fall or a direct blow to the shoulder.5There are four main types of SLAP lesions: in this research including from type II to type IV . SLAP type II is characterized by superior part of the labrum , along with the biceps tendon is detached from the glenoid . SLAP type III is characterized by bucket handle tear of the superior labrum , where a piece of the labrum detaches and flips into the shoulder . SLAP type IV is characterized by a bucket-handle tear of the superior labrum that extends into the biceps tendon. The prevalence of SLAP lesions as a cause of shoulder pain is estimated to be around 6-26% in the general population. 2,3,4,5,6Treatment of SLAP lesion is biceps tenodesis which was recently described, used suture anchor for fixation the biceps tendon to proximal humerus to obtain the stability of glenohumeral muscle. Fixation methods include tenodesis through a bone tunnel which have a role in pain relief and maintain biceps muscle strength and have a role in preventing cramping.7,8 Recently treatment of SLAP lesion is repairing the labrum using suture anchors with Biceps tenodesis.1 This study prepared to compare the results of biceps tenodesis alone Versus biceps tenodesis and labrum repair in superior labrum anteroposterior (SLAP) Lesion from type II to type IV .
- Conditions
- SLAP Lesion
- Being tested
- Biceps tenodesis alone, Biceps tenodesis and labrum repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biceps tenodesis aloneProcedure or surgery
Biceps tenodesis in superior labrum anteroposterior lesion from type II to type IV
Biceps tenodesis and labrum repairProcedure or surgery
Biceps tenodesis and labrum repair by anchors in superior labrum anteroposterior lesion from type II to type IV
| Study group | Role | What they receive |
|---|---|---|
| Biceps tenodesis alone | Other | Not described Receives: Procedure: Biceps tenodesis alone |
| Biceps tenodesis and labrum repair | Other | Not described Receives: Procedure: Biceps tenodesis and labrum repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome by American shoulder elbow score
Examination of the patients and ask them about their pain degree and record the results
Measured: 12 months
VAS score
Examination of the patients and ask them about their pain degree and record the results
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLAP LesionStudies 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
- Model description
- 2 parallel groups selected by Randomisation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahrous Fouad Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113821
- Sponsor's protocol ID
- SLAP lesion from type II to IV
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 24 Aug 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV
- ClinicalTrials.gov ID
- NCT07113821
- Acronym / sponsor ID
- SLAP lesion from type II to IV
- Conditions
- SLAP Lesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 11 Aug 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.
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV
Detailed description
A SLAP (Superior Labrum Anterior to Posterior) lesion is a specific type of shoulder injury that involves damage to the superior labrum, which is the cartilage rim around the socket of the shoulder joint. This type of injury typically occurs at the long head of the biceps tendon attaches to the labrum. The patient may feel pain, popping sensations and decreased range of motion in the shoulder.1 SLAP lesions are occurring in younger individuals,who playing sports that require repetitive overhead motions and presenting in individuals who have shoulder trauma injury,such as a fall or a direct blow to the shoulder.5There are four main types of SLAP lesions: in this research including from type II to type IV . SLAP type II is characterized by superior part of the labrum , along with the biceps tendon is detached from the glenoid . SLAP type III is characterized by bucket handle tear of the superior labrum , where a piece of the labrum detaches and flips into the shoulder . SLAP type IV is characterized by a bucket-handle tear of the superior labrum that extends into the biceps tendon. The prevalence of SLAP lesions as a cause of shoulder pain is estimated to be around 6-26% in the general population. 2,3,4,5,6Treatment of SLAP lesion is biceps tenodesis which was recently described, used suture anchor for fixation the biceps tendon to proximal humerus to obtain the stability of glenohumeral muscle. Fixation methods include tenodesis through a bone tunnel which have a role in pain relief and maintain biceps muscle strength and have a role in preventing cramping.7,8 Recently treatment of SLAP lesion is repairing the labrum using suture anchors with Biceps tenodesis.1 This study prepared to compare the results of biceps tenodesis alone Versus biceps tenodesis and labrum repair in superior labrum anteroposterior (SLAP) Lesion from type II to type IV .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 parallel groups selected by Randomisation
| Arm | Type | Receives |
|---|---|---|
| Biceps tenodesis alone | Other | Procedure: Biceps tenodesis alone |
| Biceps tenodesis and labrum repair | Other | Procedure: Biceps tenodesis and labrum repair |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Traumatic and degenerative etiology.
- No shoulder deformity .
- No inflammatory joint disorders.
- Type of the SLAP is SLAP lesion from type II to type IV
Key exclusion criteria (5 listed)
- History of the disease.
- Bilateral shoulder.
- DM .
- Epilepsy .
- psychological disturbance.
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 |
|---|---|---|
| Biceps tenodesis aloneBiceps tenodesis in superior labrum anteroposterior lesion from type II to type IV | Procedure or surgery | Biceps tenodesis alone |
| Biceps tenodesis and labrum repairBiceps tenodesis and labrum repair by anchors in superior labrum anteroposterior lesion from type II to type IV | Procedure or surgery | Biceps tenodesis and labrum repair |
Primary outcome
Clinical outcome by American shoulder elbow score
Time frame: 12 months
Examination of the patients and ask them about their pain degree and record the results
VAS score
Time frame: 12months
Examination of the patients and ask them about their pain degree and record the results
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 24 Aug 2025.
- American Academy of Orthopaedic Surgeons. (2018). SLAP Tears. Retrieved from https://orthoinfo.aaos.org/en/diseases--conditions/slap-tears/.Link provided by the sponsor.
Related trials for SLAP Lesion
Recruiting
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
SLAP Lesion
Not yet recruitingObservational study
Reliability and Accuracy of a New Clinical Test for Biceps Lesions
Lesion of Long Head of Biceps, SLAP Lesion
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.
Questions about this trial
What is this clinical trial studying?
A study testing Biceps tenodesis alone and Biceps tenodesis and labrum repair in people with SLAP Lesion, run by Assiut University.
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 4 inclusion and 5 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mohammed, Resident (01018178956, Ahmed.15257716@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome by American shoulder elbow score (time frame: 12 months). The study lists 2 primary outcomes in all. 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 24 Aug 2025.