Repair Versus Augmentation of Partial ACL Tear
Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05391672
Collaborator
(none)
72
2
13
Study Details
Study Description
Brief Summary
Comparison between ACL repair and ACL augmentation in symptomatic patients with partial ACL injury
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Repair Versus Augmentation Of Partial Anterior Cruciate Ligament Tear
Anticipated Study Start Date
:
Dec 1, 2022
Anticipated Primary Completion Date
:
Dec 1, 2023
Anticipated Study Completion Date
:
Jan 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Repair group Repair of partial torn ACL by suturing stump and fixation to femoral footprint by anchors |
Procedure: Repair or Aumentation of partial ACL tear
We will use repair technique in one grouo and Augmentation in the other group
|
| 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 |
Procedure: Repair or Aumentation of partial ACL tear
We will use repair technique in one grouo and Augmentation in the other group
|
Outcome Measures
Primary Outcome Measures
- The main outcome is difference in IKDC scores between two groups of patients [Baseline]
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
- Study Director: Mohamed Abd-El Radi, Lecturer, Orthopaedic Department , Faculty of medicine, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Review.
Responsible Party:
Michael Mikhaeil Attallah Gendy,
Michael Mikhaeil,
Assiut University
ClinicalTrials.gov Identifier:
NCT05391672
Other Study ID Numbers:
- Repair Vs Augmentation ACL
First Posted:
May 26, 2022
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: