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Orthopedic Surgery

High Tibial Osteotomy + Non-Surgical Treatment for Knee Osteoarthritis

N/A
Waitlist Available
Led By J R Giffin, MD
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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MRI articular cartilage morphology
Secondary outcome measures
Biological Markers of Disease Progression
Gait Biomechanics
Intermittent and Constant Osteoarthritis Pain Index (ICOAP)
+6 more
Other outcome measures
Cost-effectiveness questionnaires

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.

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,346 Total Patients Enrolled
20 Trials studying Osteoarthritis
902,347 Patients Enrolled for Osteoarthritis
Western University, CanadaLead Sponsor
239 Previous Clinical Trials
57,412 Total Patients Enrolled
9 Trials studying Osteoarthritis
814 Patients Enrolled for Osteoarthritis
The Arthritis Society, CanadaOTHER
24 Previous Clinical Trials
5,551 Total Patients Enrolled
7 Trials studying Osteoarthritis
1,391 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
Trevor Birmingham 2014. "A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02003976.
~7 spots leftby Apr 2025
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