5 Step Mini-open Method of Massive Rotator Cuff Repair
The 5-step Mini-open Method of Massive Rotator Cuff Repair and Clinical and Radiological Outcome
1 other identifier
observational
48
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedFirst Submitted
Initial submission to the registry
January 27, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedFebruary 5, 2024
January 1, 2024
4.3 years
January 27, 2024
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
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
Eligibility Criteria
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
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