- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06858943
Can Tendon Autograft Function As a Meniscal Transplant (DR)
March 6, 2025 updated by: Mohamed hussein khalil, Cairo University
Purpose: To evaluate the functional outcomes after using peroneus longus (PL) tendon autograft as meniscal transplantation in patients with knee joint line pain exaggerated with weight bearing following prior total or subtotal meniscectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This research design is a single center prospective study carried out at a tertiary trauma center hospital between May 2022 and December 2022.
This research had ethical Committee Approval which was granted by the Ethics Committee of Cairo University (Institutional Review Board (IRB) number N 207-2024).
All patients signed an informed consent before joining this study.
This study included 25 patients, with previous history of subtotal or total meniscectomy medially or laterally, who underwent meniscus transplantation using PL tendon autograft.
Study Type
Interventional
Enrollment (Actual)
25
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 Locations
-
-
Cairo
-
Giza, Cairo, Egypt
- Faculty of Medicine, Cairo University
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Skeletally mature patients with a history of prior subtotal or total (medial or lateral meniscus) meniscectomy.
- Post meniscectomy symptoms (medial or lateral knee joint line pain exaggerated with weight bearing).
Exclusion Criteria:
- Multi-ligamentous knee injuries.
- Skeletally immature patients.
- Significant osteoarthritic changes on radiographs (Ahlbäck II- V).
- Malalignment on full-length radiographs showing increased stress in the involved knee compartment.
- Presence of associated ipsilateral ankle joint problem.
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 |
|---|---|
|
Experimental: arthroscopic meniscus reconstruction using a tendon autograft
|
arthroscopic meniscus reconstruction using a tendon autograft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lysholm knee score
Time Frame: baseline, 2 years postoperative
|
functional knee score, minimum is zero, maximum value is 100, a higher score means a better outcome
|
baseline, 2 years postoperative
|
|
Knee Injury and Osteoarthritis and Outcome (KOOS) score
Time Frame: baseline, and 2 years postoperative
|
osteoarthritis knee score, minimum is zero, maximum is 100, higher score means a better outcome
|
baseline, and 2 years postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: mohamed H khalil, M.D, Cairo 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
- Ronnblad E, Rotzius P, Eriksson K. Autologous semitendinosus tendon graft could function as a meniscal transplant. Knee Surg Sports Traumatol Arthrosc. 2022 May;30(5):1520-1526. doi: 10.1007/s00167-021-06606-8. Epub 2021 Jun 8.
- Kohn D. Autograft meniscus replacement: experimental and clinical results. Knee Surg Sports Traumatol Arthrosc. 1993;1(2):123-5. doi: 10.1007/BF01565466.
- Johnson LL, Feagin JA Jr. Autogenous tendon graft substitution for absent knee joint meniscus: a pilot study. Arthroscopy. 2000 Mar;16(2):191-6. doi: 10.1016/s0749-8063(00)90035-5.
- Milenin O, Strafun S, Sergienko R, Baranov K. Lateral Meniscus Replacement Using Peroneus Longus Tendon Autograft. Arthrosc Tech. 2020 Jul 22;9(8):e1163-e1169. doi: 10.1016/j.eats.2020.04.016. eCollection 2020 Aug.
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)
May 1, 2022
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
February 28, 2025
First Submitted That Met QC Criteria
February 28, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 6, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- N 207-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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