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Orthopedic Surgery

High Tibial Osteotomy + Non-Surgical Treatment for Knee Osteoarthritis

N/A

Waitlist Available

Led By Trevor B Birmingham, PT, PhD

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Does this subject have clinical Knee OA? (MAA <-2° on full limb standing AP) according to the Altman classification primarily involving the medial compartment of the knee?

Patient is a good candidate for high tibial osteotomy and will be receiving a PEEK plate, or if receiving an alternate plate, agrees to have the plate removed prior to 1 year postoperative.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 and 24 months post operative

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether surgery can improve quality of life for people with knee osteoarthritis, in addition to optimized non-surgical treatment.

Who is the study for?

This trial is for adults aged 25-55 with knee osteoarthritis primarily in the medial compartment and varus alignment, who are good candidates for high tibial osteotomy surgery. Active individuals over 55 may also qualify. Participants must agree to potential plate removal within a year post-surgery.

What is being tested?

The study compares two approaches: surgical realignment of the shinbone (tibia) plus non-surgical treatments versus non-surgical treatments alone for knee osteoarthritis. The goal is to see which method better improves patient outcomes after one and two years.

What are the potential side effects?

Potential side effects from the surgical intervention include pain at the surgery site, infection risk, blood clots, nerve damage around the operated area, and complications related to bone healing or plate placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have knee osteoarthritis mainly affecting the inner side of my knee.

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I am a good candidate for leg surgery and agree to the terms regarding the plate used.

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I am between 25 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 and 24 months post operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 and 24 months post operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 and 24 months post operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MRI articular cartilage morphology

Secondary study objectives

Biological Markers of Disease Progression

Gait Biomechanics

Intermittent and Constant Osteoarthritis Pain Index (ICOAP)

+6 more

Other study objectives

Cost-effectiveness questionnaires

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-Surgical Treatment plus HTOExperimental Treatment2 Interventions

The optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will undergo a medial opening wedge high tibial osteotomy (HTO). They will continue with their home program and will be followed up for 2 years after baseline.

Group II: Non-Surgical TreatmentActive Control1 Intervention

The optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will continue with their home program and will be followed up for 2 years after baseline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Medial Opening Wedge High Tibial Osteotomy (HTO)

2014

N/A

~80

0 / 3Eligibility criteria met