NCT06394856

Brief Summary

rotator cuff tears are one of the most common shoulder issues , affecting 20.7% of the general population .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

April 21, 2024

Last Update Submit

June 12, 2024

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

  • retear rate

    retear rate

    3 years

Secondary Outcomes (1)

  • time

    3 years

Study Arms (2)

knotless group

ACTIVE COMPARATOR

rotator cuff repair with a modified knotless anchors

Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques

knot-tying group

ACTIVE COMPARATOR

rotator cuff repair with classic knot-tying double-row suture bridge technique by classic anchors

Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques

Interventions

Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge TechniquesPROCEDURE

rotator cuff tears with modified versus classic double row suture bridge

knot-tying groupknotless group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • full-thickness supraspinatus
  • degenerative tears
  • age range 40 :65

You may not qualify if:

  • subscapularis tear
  • small and massive tears
  • traumatic tears
  • partial -thickness tear
  • revisioin surgery
  • glenohumeral arthretic changes and shoulder instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university Hospital

Sohag, 82511, Egypt

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Hossam M azab, MD

    Sohag University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor orthopedic department

Study Record Dates

First Submitted

April 21, 2024

First Posted

May 1, 2024

Study Start

July 1, 2018

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations

EG(1)