MeniscectomyDRNCT06858943
Can Tendon Autograft Function As a Meniscal Transplant
A study testing arthroscopic meniscus reconstruction using a tendon autograft in people with Meniscectomy, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 40 years
- Conditions the study is for
- Meniscectomy
- What is being tested?
- arthroscopic meniscus reconstruction using a tendon autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Meniscectomy
- Being tested
- arthroscopic meniscus reconstruction using a tendon autograft
- Keywords
- Meniscus ; Peroneus longus autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic meniscus reconstruction using a tendon autograftProcedure or surgery
arthroscopic meniscus reconstruction using a tendon autograft
| Study group | Role | What they receive |
|---|---|---|
| arthroscopic meniscus reconstruction using a tendon autograft | Experimental | arthroscopic meniscus reconstruction using a tendon autograft Receives: Procedure: arthroscopic meniscus reconstruction using a tendon autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm knee score
functional knee score, minimum is zero, maximum value is 100, a higher score means a better outcome
Measured: baseline, 2 years postoperative
Knee Injury and Osteoarthritis and Outcome (KOOS) score
osteoarthritis knee score, minimum is zero, maximum is 100, higher score means a better outcome
Measured: baseline, and 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 May 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MeniscectomyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- case series of 25 patients
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed hussein khalil, Cairo University
- Investigators
- mohamed H khalil, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858943
- Sponsor's protocol ID
- N 207-2024
- Acronym
- DR
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34100999Kohn D. Autograft meniscus replacement: experimental and clinical results. Knee Surg Sports Traumatol Arthrosc. 1993;1(2):123-5. doi: 10.1007/BF01565466.
PubMed 8536007Johnson 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.
PubMed 10705332Milenin 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.
PubMed 32874897
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Tendon Autograft Function As a Meniscal Transplant
- ClinicalTrials.gov ID
- NCT06858943
- Acronym / sponsor ID
- DR / N 207-2024
- Conditions
- Meniscectomy
- Keywords
- Meniscus ; Peroneus longus autograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case series of 25 patients
| Arm | Type | Receives |
|---|---|---|
| arthroscopic meniscus reconstruction using a tendon autograft | Experimental | Procedure: arthroscopic meniscus reconstruction using a tendon autograftarthroscopic meniscus reconstruction using a tendon autograft |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic meniscus reconstruction using a tendon autograftarthroscopic meniscus reconstruction using a tendon autograft | Procedure or surgery | arthroscopic meniscus reconstruction using a tendon autograft |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 34100999Ronnblad 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.
- Background: PubMed 8536007Kohn D. Autograft meniscus replacement: experimental and clinical results. Knee Surg Sports Traumatol Arthrosc. 1993;1(2):123-5. doi: 10.1007/BF01565466.
- Background: PubMed 10705332Johnson 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.
- Background: PubMed 32874897Milenin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed H khalil, M.D principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic meniscus reconstruction using a tendon autograft in people with Meniscectomy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm knee score (time frame: baseline, 2 years postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06858943, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.