Arthroscopic Repair Versus High Tibial Osteotomy for Medial Meniscus Posterior Root Tears
Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05971472
Collaborator
(none)
30
1
2
38.6
0.8
Study Details
Study Description
Brief Summary
The goal of the trial is to compare Arthroscopic repair against Opening wedge high tibial osteotomy for Medial Meniscus posterior root tears
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
All Patients included in this clinical trial will be informed by written consent will undergo a one week screening to determine the eligibility for study entry.
Patients who meet the eligibility requirements will be randomized in a single blinded manner (patients).
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
single (participant)
Primary Purpose:
Treatment
Official Title:
Arthroscopic Repair Versus Opening Wedge High Tibial Osteotomy for Medial Meniscus Posterior Root Tears
Actual Study Start Date
:
Sep 12, 2021
Anticipated Primary Completion Date
:
Sep 1, 2023
Anticipated Study Completion Date
:
Dec 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arthroscopic Repair Arthroscopic Repair for medial meniscus posterior root tears |
Procedure: Arthroscopic Repair
Arthroscopic Repair for medial meniscus posterior Root tears
|
| Active Comparator: High tibial osteotomy Open wedge High tibial osteotomy for medial meniscus posterior root tears |
Procedure: High tibial osteotomy
Open Wedge High tibial osteotomy for medial meniscus posterior Root tears
|
Outcome Measures
Primary Outcome Measures
- Lysholm Score [3 month and 6 month]
Validated Arabic form of Lyshlom score
- IKDC Score [3 month and 6 month]
Validated Arabic form of IKDC score
Secondary Outcome Measures
- infection [3 month and 6 month]
Occurrence of infection
- Non union [3 month and 6 month]
Occurrence of delayed or non union
- Arthrofibrosis [3 month and 6 month]
Loss of knee ROM or occurrence of Arthrofibrosis
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Sex: both sexes.
-
Age: Above 40
-
Degree of Varus: Neutral to 10 degrees of Varus
Exclusion Criteria:
-
History of high energy trauma.
-
Multiligamentous knee Injury.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Demerdash Hospital | Cairo | Egypt |
Sponsors and Collaborators
- Ain Shams University
Investigators
- Study Director: Wael S. Abdel Megid, Professor, Ain Shams University
- Study Director: Zeiad M. Zakaria, Assistant Professor, Ain Shams University
- Study Director: Radwan G. Abdel Hamid, Assistant Professor, Ain Shams University
- Study Director: Mohamed E. Awad, Assistant Professor, Ain Shams University
Study Documents (Full-Text)
None provided.More Information
Publications
- Feucht MJ, Kuhle J, Bode G, Mehl J, Schmal H, Sudkamp NP, Niemeyer P. Arthroscopic Transtibial Pullout Repair for Posterior Medial Meniscus Root Tears: A Systematic Review of Clinical, Radiographic, and Second-Look Arthroscopic Results. Arthroscopy. 2015 Sep;31(9):1808-16. doi: 10.1016/j.arthro.2015.03.022. Epub 2015 May 13.
- Kim KI, Bae JK, Jeon SW, Kim GB. Medial Meniscus Posterior Root Tear Does Not Affect the Outcome of Medial Open-Wedge High Tibial Osteotomy. J Arthroplasty. 2021 Feb;36(2):423-428. doi: 10.1016/j.arth.2020.08.067. Epub 2020 Sep 7.
- Marzo JM, Gurske-DePerio J. Effects of medial meniscus posterior horn avulsion and repair on tibiofemoral contact area and peak contact pressure with clinical implications. Am J Sports Med. 2009 Jan;37(1):124-9. doi: 10.1177/0363546508323254. Epub 2008 Sep 24.
- Nha KW, Lee YS, Hwang DH, Kwon JH, Chae DJ, Park YJ, Kim JI. Second-look arthroscopic findings after open-wedge high tibia osteotomy focusing on the posterior root tears of the medial meniscus. Arthroscopy. 2013 Feb;29(2):226-31. doi: 10.1016/j.arthro.2012.08.027. Erratum In: Arthroscopy. 2019 Feb;35(2):691. Arthroscopy. 2020 Mar;36(3):923.
Responsible Party:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT05971472
Other Study ID Numbers:
- FMASU MD 169/2021
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ain Shams University