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Not yet recruitingNCT06300190Updated Mar 12, 2024

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

An interventional study of Biceps tenodesis alone and Biceps tenodesis and labrum repair in SLAP Lesion, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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 ?

02

Conditions studied

  • SLAP Lesion
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Traumatic and degenerative etiology.
  • No shoulder deformity .
  • No inflammatory joint disorders.
  • Type of the SLAP is SLAP type IV.

Exclusion criteria

Exclusion Criteria:

  • History of the disease.
  • Bilateral shoulder.
  • DM .
  • Epilepsy .
  • psychological disturbance.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Biceps tenodesis alone

    Procedure: Biceps tenodesis alone

  • Other
    Biceps tenodesis and repair labrum

    Procedure: Biceps tenodesis and labrum repair

Interventions

  • ProcedureBiceps tenodesis alone

    Biceps tenodesis in superior labrum anteroposterior lesion type IV

  • ProcedureBiceps tenodesis and labrum repair

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

06

What researchers measure

Primary outcomes

  1. Clinical outcome by American shoulder elbow score

    Examination of the patients and ask them about their pain degree and record the results

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06300190
Lead sponsor
Assiut University
Responsible party
Ahmed Mahrous Fouad Mohamed (Resident of orthopaedic and trauma surgery Assiut university hospital, Assiut University) — Principal investigator
First posted
Mar 8, 2024
Start date
Mar 2024 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Mar 12, 2024

Study contacts

Ahmed Mohamed, Resident
Contact
Ahmed.15257716@med.aun.edu.eg
01018178956
Mohammed Abd El-hameid, Prof.Dr
Contact
Mohamed.abdelhamid@med.aun.edu.eg
01111230095

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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