NCT06242158

Brief Summary

48 patients with massive rotator cuff tears were treated with a standardized five step technique of arthroscopic guided mini-open tranosseous repair with bursal augmentation. Their follow up is noted

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

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

September 19, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

4.3 years

First QC Date

January 27, 2024

Last Update Submit

January 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Constant score

    for function of shoulder

    (Pre operative) then at post operative 1 year and 2 years

Secondary Outcomes (2)

  • Vas score

    (Pre operative) then at post operative 1 year and 2 years

  • UCLA score

    (Pre operative) then at post operative 1 year and 2 years

Study Arms (1)

Case with massive rotator cuff tear

Case with massive rotator cuff tear defined as more than 2 complete tendon tear that is repairable

Procedure: arthroscopic assisted mini-open 5 step repair

Interventions

First step Identifying the tear size , quality and if reducible on the foot print . minimal removal of the bursa and pulling of the tendon with a grasper to reach the foot print area with gentle mobilization of the tendon . Step two Acromioplasty Using a probe, the LHBT was palpated and mobilized, looking for any signs of degeneration and fraying or instability . The LHBT was inspected either through the tear by the subacrominal portal or through the glenohumeral portal . Step three Antero-lateral mini-open approach was used through a longitudinal 4 cm skin incision Step four Transosseous repair using the giant needle was used. 3 to 4 number two fiber wire sutures was passed equidistance through the tendon Step five The subarominal bursa was used for biological augmentation of the repair

Case with massive rotator cuff tear

Eligibility Criteria

Age60 Years - 84 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

These are patients who presented to cairo university hospitals between 2019 and 2023

You may qualify if:

  • a case with massive rotator cuff tear that is repairable (judged intraoperative by arthroscope that the tear returns to its footprint)
  • ages from 60 to 84

You may not qualify if:

  • Osteoarthritis
  • associated fractures
  • younger than 60 orolder than 84

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Hospital - Faculty of Medicine - Cairo University

Cairo, 11765, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 27, 2024

First Posted

February 5, 2024

Study Start

September 19, 2019

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Locations