Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV

NCT ID: NCT06300190

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2025-07-31

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Biceps tenodesis alone

Group Type: OTHER

Biceps tenodesis alone

Intervention Type: PROCEDURE

Biceps tenodesis in superior labrum anteroposterior lesion type IV

Biceps tenodesis and repair labrum

Group Type: OTHER

Biceps tenodesis and labrum repair

Intervention Type: PROCEDURE

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

Interventions

Biceps tenodesis alone

Biceps tenodesis in superior labrum anteroposterior lesion type IV

Intervention Type: PROCEDURE

Biceps tenodesis and labrum repair

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mahrous Fouad Mohamed

Resident of orthopaedic and trauma surgery Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Mohamed, Resident

Role: CONTACT

Ahmed.15257716@med.aun.edu.eg

01018178956

Mohammed Abd El-hameid, Prof.Dr

Role: CONTACT

Mohamed.abdelhamid@med.aun.edu.eg

01111230095

Related Links

http://orthoinfo.aaos.org/en/diseases--conditions/slap-tears/

American Academy of Orthopaedic Surgeons. (2018). SLAP Tears. Retrieved from https://orthoinfo.aaos.org/en/diseases--conditions/slap-tears/.

Other Identifiers

Treatment SLAP type IV lesion

Identifier Type: -

Identifier Source: org_study_id