Clinical and Radiographic Outcomes of Medial Open-wedge High Tibial Osteotomy

September 14, 2019 updated by: Mohamed Salah Abdelhamid Ahmed, Assiut University

Effect of Medial Open Wedge High Tibial Osteotomy on Clinical and Radiographic Outcomes of Patients With Knee Osteoarthritis : A Retrospective Study

Osteoarthritis is a common degenerative disorder of the articular cartilage . Risk factors include genetics, female sex, past trauma, advancing age, and obesity. The diagnosis is based on a history of joint pain worsened by movement, which can lead to disability in activities of daily living .

Diagnosis of knee osteoarthritis can be confirmed based on clinical and/or radiological features. The potential of a progressive disease can be prevented or decreased by earlier recognition and correction of associated factors. Obesity and alignment especially varus malalignment are recognized factors of a progressive disease.

High tibial osteotomy (HTO) is a widely performed procedure, and good results can be achieved with appropriate patient selection and precise surgical technique. It is reported to be an effective treatment for varus knee osteoarthritis (OA) by redistributing the load line within the knee joint . With an HTO, the surgeon aims to change the coronal alignment of the leg in order to shift the center of force passing axially through the knee from the arthritic region of the knee towards the unaffected side. The amount of alignment correction to be performed is calculated before surgery based on the extent of knee arthrosis and on the alignment of the patient's lower limbs on long-leg weight bearing radiographs .

Our study is focused on effectiveness of open wedge High tibial osteotomy on clinical and radiographic outcomes of patients with medial knee osteoarthritis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a retrospective case-series study of at least 40 patients , who underwent medial open-wedge HTO for treatment of medial knee osteoarthritis between January 2016 and January 2019 in our Arthroscopy and Sports Injuries Unit in Orthopaedics Department of Assiut University. Inclusion criteria is Kellgren-Lawrence classification grades 1 to 3; symptomatic unicompartmental osteoarthritis

Pre-operative :

assessment of patients is done clinically using Knee society score (KSS) and visual analogue scale (VAS) (0 mm, no pain;100 mm, worst pain) and radiographic assessment according to Kellgren and Lawrence using anteroposterior (AP) and lateral x-ray views of the knee , a two-leg long standing view with or without slight flexion assessing Femoral-tibial angle (FTA) .

Intra-operative :

After anaesthesia is induced, an arthroscopic examination is performed to define the status of the menisci (excluding significant damage of the lateral compartment), cruciate ligaments, and articular cartilage. meniscal surgery (partial menisectomy/meniscal repair) is performed when necessary, then The medial open wedge high tibial osteotomy (MOWHTO) is performed.

Post-operative :

follow up after at least 1 year post-operative clinically using knee society score (KSS) , visual analogue scale (VAS),Knee Injury and Osteoarthritis Outcome Score(KOOS) , Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index scores and radiological assessment using Anteroposterior and lateral views xrays assessing union two-leg long standing view x ray with or without slight flexion assessing Femoral-tibial angle (FTA) and joint line .

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients older than 30 years old that underwent medial open wedge high tibial osteotomy due to medial osteoarthritis of the knee

Description

Inclusion Criteria:

  • Age above 30 years old.
  • Patients who had MOWHTO for knee OA within the past 5 years .
  • No response to non-surgical treatment (medical and physiotherapy) pre operatively for at least 3 months.
  • Intact cruciate ligaments, and Collateral ligaments.

Exclusion Criteria:

  • Age less than 30 years old.
  • Patients who had HTO for another reasons other than knee OA.
  • Combined injury to (collateral ligaments, cruciate ligament).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain relief is being assessed using Visual analogue scale (VAS)
Time Frame: 1 year up to 5 years post operative
assessment is done using Visual analogue scale (VAS)
1 year up to 5 years post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
varus malalignment correction of the knee
Time Frame: 1 year up to 5 years post operative
this is measured using femoral tibial angle
1 year up to 5 years post operative

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Mohamed M. Abdelhamid, PHD, Professor of Orthopedics and Traumatology
  • Study Director: Islam K. Ramadan, PHD, Lecturer of Orthopedics and Traumatology

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 (ANTICIPATED)

October 1, 2019

Primary Completion (ANTICIPATED)

September 30, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (ACTUAL)

July 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 14, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOWHTO in OA

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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