NCT06858943

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

February 28, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

Meniscus ; Peroneus longus autograft

Outcome Measures

Primary Outcomes (2)

  • Lysholm knee score

    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

    osteoarthritis knee score, minimum is zero, maximum is 100, higher score means a better outcome

    baseline, and 2 years postoperative

Study Arms (1)

arthroscopic meniscus reconstruction using a tendon autograft

EXPERIMENTAL

arthroscopic meniscus reconstruction using a tendon autograft

Procedure: arthroscopic meniscus reconstruction using a tendon autograft

Interventions

arthroscopic meniscus reconstruction using a tendon autograft

arthroscopic meniscus reconstruction using a tendon autograft

Eligibility Criteria

Age22 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Giza, Cairo Governorate, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 34100999BACKGROUND
  • Kohn D. Autograft meniscus replacement: experimental and clinical results. Knee Surg Sports Traumatol Arthrosc. 1993;1(2):123-5. doi: 10.1007/BF01565466.

    PMID: 8536007BACKGROUND
  • 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.

    PMID: 10705332BACKGROUND
  • 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.

    PMID: 32874897BACKGROUND

Study Officials

  • mohamed H khalil, M.D

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: case series of 25 patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 5, 2025

Study Start

May 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations