SLAP LesionNCT06300190
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion 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
Aim of this study is comparing results Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion 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
- Mar 2024to Jul 2025
- 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 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 type IV.
Who cannot join
- History of the disease.
- Bilateral shoulder.
- DM .
- Epilepsy .
- psychological disturbance.
Trial locations and contacts
No sites are listed yet.
About this study
Aim of this study is comparing results Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion 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 Type IV: That is characterized by a bucket-handle tear of the superior labrum that extends into the biceps tendon. The torn portion of the labrum is displaced into the joint and the biceps tendon may be partially or completely detached.The prevalence of SLAP lesions as a cause of shoulder pain is estimated to be around 6-26% in the general population. However, the prevalence can vary depending on the specific population being studied, such as athletes or individuals with specific occupations that involve repetitive overhead activities.Treatment of SLAP type IV 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, the keyhole method, soft tissue tenodesis to the rotator interval or conjoint tendon, interference screw fixation, and suture anchors tenodesis which have a role in pain relief and maintain biceps muscle strength and have a role in preventing cramping. Recently treatment of SLAP lesion is repairing the labrum using suture anchors with Biceps tenodesis.This study prepared to compare the results of Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion 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 type IV
Biceps tenodesis and labrum repairProcedure or surgery
Biceps tenodesis and labrum repair by anchors in superior labrum anteroposterior lesion type IV
| Study group | Role | What they receive |
|---|---|---|
| Biceps tenodesis alone | Other | Not described Receives: Procedure: Biceps tenodesis alone |
| Biceps tenodesis and repair labrum | 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 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
- NCT06300190
- Sponsor's protocol ID
- Treatment SLAP type IV lesion
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2024
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. 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) Lesion Type IV
- ClinicalTrials.gov ID
- NCT06300190
- Acronym / sponsor ID
- Treatment SLAP type IV lesion
- Conditions
- SLAP Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 8 Mar 2024 (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.
Aim of this study is comparing results Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion 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 Type IV: That is characterized by a bucket-handle tear of the superior labrum that extends into the biceps tendon. The torn portion of the labrum is displaced into the joint and the biceps tendon may be partially or completely detached.The prevalence of SLAP lesions as a cause of shoulder pain is estimated to be around 6-26% in the general population. However, the prevalence can vary depending on the specific population being studied, such as athletes or individuals with specific occupations that involve repetitive overhead activities.Treatment of SLAP type IV 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, the keyhole method, soft tissue tenodesis to the rotator interval or conjoint tendon, interference screw fixation, and suture anchors tenodesis which have a role in pain relief and maintain biceps muscle strength and have a role in preventing cramping. Recently treatment of SLAP lesion is repairing the labrum using suture anchors with Biceps tenodesis.This study prepared to compare the results of Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion 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 repair labrum | 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 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 type IV | Procedure or surgery | Biceps tenodesis alone |
| Biceps tenodesis and labrum repairBiceps tenodesis and labrum repair by anchors in superior labrum anteroposterior lesion type IV | Procedure or surgery | Biceps tenodesis and repair labrum |
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- 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
Not yet recruiting
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV
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. This study is not recruiting at the moment.
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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed, 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). 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 12 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.