NCT05971472

Brief Summary

The goal of the trial is to compare Arthroscopic repair against Opening wedge high tibial osteotomy for Medial Meniscus posterior root tears

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 12, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

July 25, 2023

Last Update Submit

July 25, 2023

Conditions

Medial Mensical Tear

Keywords

MedialMeniscusPosteriorRootTearHigh Tibial OsteotomyArthroscopic Root RepairTranstibial PulloutArthroscopic RepairOpen Wedge

Outcome Measures

Primary Outcomes (2)

  • Lysholm Score

    Validated Arabic form of Lyshlom score

    3 month and 6 month

  • IKDC Score

    Validated Arabic form of IKDC score

    3 month and 6 month

Secondary Outcomes (3)

  • infection

    3 month and 6 month

  • Non union

    3 month and 6 month

  • Arthrofibrosis

    3 month and 6 month

Study Arms (2)

Arthroscopic Repair

ACTIVE COMPARATOR

Arthroscopic Repair for medial meniscus posterior root tears

Procedure: Arthroscopic Repair

High tibial osteotomy

ACTIVE COMPARATOR

Open wedge High tibial osteotomy for medial meniscus posterior root tears

Procedure: High tibial osteotomy

Interventions

Arthroscopic RepairPROCEDURE

Arthroscopic Repair for medial meniscus posterior Root tears

Arthroscopic Repair
High tibial osteotomyPROCEDURE

Open Wedge High tibial osteotomy for medial meniscus posterior Root tears

High tibial osteotomy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sex: both sexes.
  • Age: Above 40
  • Degree of Varus: Neutral to 10 degrees of Varus

You may not qualify if:

  • History of high energy trauma.
  • Multiligamentous knee Injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demerdash Hospital

Cairo, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 32978022BACKGROUND

  • 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.

    PMID: 23369476BACKGROUND

  • 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.

    PMID: 18815238BACKGROUND

  • 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.

    PMID: 25979687BACKGROUND

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • 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 DIRECTOR

Central Study Contacts

Amr S. Ahmed, Master

CONTACT

+201113742474AmrElhady@med.asu.edu.eg

Amr S. Ahmed, Master

CONTACT

+201008026969amrsamyelhady@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single (participant)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

September 12, 2021

Primary Completion

September 1, 2023

Study Completion

December 1, 2024

Last Updated

August 2, 2023

Record last verified: 2023-07

Locations

EG(1)