NCT06300190

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

March 2, 2024

Last Update Submit

March 9, 2024

Conditions

SLAP Lesion

Outcome Measures

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

    12 months

Study Arms (2)

Biceps tenodesis alone

OTHER
Procedure: Biceps tenodesis alone

Biceps tenodesis and repair labrum

OTHER
Procedure: Biceps tenodesis and labrum repair

Interventions

Biceps tenodesis alonePROCEDURE

Biceps tenodesis in superior labrum anteroposterior lesion type IV

Biceps tenodesis alone
Biceps tenodesis and labrum repairPROCEDURE

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

Biceps tenodesis and repair labrum

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Central Study Contacts

Ahmed Mohamed, Resident

CONTACT

01018178956Ahmed.15257716@med.aun.edu.eg

Mohammed Abd El-hameid, Prof.Dr

CONTACT

01111230095Mohamed.abdelhamid@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Aim of this study is comparing outcome results of Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 parallel groups selected by Randomisation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of orthopaedic and trauma surgery Assiut university hospital

Study Record Dates

First Submitted

March 2, 2024

First Posted

March 8, 2024

Study Start

March 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

March 12, 2024

Record last verified: 2024-03