Arthroscopic Repair Versus High Tibial Osteotomy for Medial Meniscus Posterior Root Tears (Root Tears)

July 25, 2023 updated by: Ain Shams University

Arthroscopic Repair Versus Opening Wedge High Tibial Osteotomy for Medial Meniscus Posterior Root Tears

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Demerdash Hospital

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm Score
Time Frame: 3 month and 6 month
Validated Arabic form of Lyshlom score
3 month and 6 month
IKDC Score
Time Frame: 3 month and 6 month
Validated Arabic form of IKDC score
3 month and 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection
Time Frame: 3 month and 6 month
Occurrence of infection
3 month and 6 month
Non union
Time Frame: 3 month and 6 month
Occurrence of delayed or non union
3 month and 6 month
Arthrofibrosis
Time Frame: 3 month and 6 month
Loss of knee ROM or occurrence of Arthrofibrosis
3 month and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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

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)

September 12, 2021

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMASU MD 169/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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