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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06300190
Other study ID # Treatment SLAP type IV lesion
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date July 2025

Study information

Verified date March 2024
Source Assiut University
Contact Ahmed Mohamed, Resident
Phone 01018178956
Email Ahmed.15257716@med.aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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 ?


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date July 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Traumatic and degenerative etiology. - No shoulder deformity . - No inflammatory joint disorders. - Type of the SLAP is SLAP type IV. Exclusion Criteria: - History of the disease. - Bilateral shoulder. - DM . - Epilepsy . - psychological disturbance.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biceps tenodesis alone
Biceps tenodesis in superior labrum anteroposterior lesion type IV
Biceps tenodesis and labrum repair
Biceps tenodesis and labrum repair by anchors in superior labrum anteroposterior lesion type IV

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical outcome by American shoulder elbow score Examination of the patients and ask them about their pain degree and record the results 12 months
See also
  Status Clinical Trial Phase
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Completed NCT03594071 - S&P of Q-Fix™ All-Suture Anchor System
Completed NCT03525275 - Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone After Shoulder Surgery N/A
Active, not recruiting NCT03985839 - Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip