- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05391672
Augmentation of Partial Anterior Cruciate Ligament Tear: Early Results (Augmentation)
December 17, 2025 updated by: Michael Mikhaeil Attallah Gendy, Assiut University
Clinical evaluation for the patients with partial ACL tear who had ACL augmentation
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
we will do a clinical evaluation depending mainly on IKDC score for patients with partial ACL tear who undergoing ACL augmentation surgery inside Assiut university hospital
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael Mikhaeil, Resident
- Phone Number: 01289375910
- Email: mickelmikhaa5@gmail.com
Study Contact Backup
- Name: Mohamed Abd-El Radi, Lecturer
- Phone Number: 01225338766
- Email: mradi@aun.edu.eg
Study Locations
-
-
-
Asyut, Egypt
- Recruiting
- Assiyt University
-
Contact:
- Mickel Mikhaa, resident
- Phone Number: +201289375910
- Email: mickelmikhaa5@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age from 15 to 50 years old
- Partial ACL tear without any other ligament injury
- with and without meniscal tear
- with and without knee deformity
- recent and chronic injury
Exclusion Criteria:
- younger than 15 and older than 50 y
- multiligament injury
- complete ACL tear
- failed ACL reconstruction or repair
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Augmentation group
We will use hamstring graft in which fixation of graft will be by adjustable loop devices for femoral part fixation & Bioscrews +/- staples for tibial part fixation
|
we will do ACL augmentation surgery to the patients who have ACL partial tear using hamstring graft and fixation of the graft to the femoral part by adjustable loop and tibial part with Bio or peak screws +\- staples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The main outcome is difference in IKDC scores between the patients
Time Frame: Baseline
|
we will evaluate the clinical outcome post operative mainly according to the difference in IKDC score between the patients
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mohamed Abd-El Radi, Lecturer, Orthopaedic Department , Faculty of medicine, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gobbi A, Whyte GP. Long-term Outcomes of Primary Repair of the Anterior Cruciate Ligament Combined With Biologic Healing Augmentation to Treat Incomplete Tears. Am J Sports Med. 2018 Dec;46(14):3368-3377. doi: 10.1177/0363546518805740. Epub 2018 Nov 6.
- Dallo I, Chahla J, Mitchell JJ, Pascual-Garrido C, Feagin JA, LaPrade RF. Biologic Approaches for the Treatment of Partial Tears of the Anterior Cruciate Ligament: A Current Concepts Review. Orthop J Sports Med. 2017 Jan 25;5(1):2325967116681724. doi: 10.1177/2325967116681724. eCollection 2017 Jan.
- Sabat D, Kumar V. Partial tears of anterior cruciate ligament: Results of single bundle augmentation. Indian J Orthop. 2015 Mar-Apr;49(2):129-35. doi: 10.4103/0019-5413.152394.
- Sharp JW, Kani KK, Gee A, Mulcahy H, Chew FS, Porrino J. Anterior cruciate ligament fixation devices: Expected imaging appearance and common complications. Eur J Radiol. 2018 Feb;99:17-27. doi: 10.1016/j.ejrad.2017.12.006. Epub 2017 Dec 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2022
Primary Completion (Estimated)
March 19, 2026
Study Completion (Estimated)
March 19, 2026
Study Registration Dates
First Submitted
May 21, 2022
First Submitted That Met QC Criteria
May 21, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
December 22, 2025
Last Update Submitted That Met QC Criteria
December 17, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17101888
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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