A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone

The purpose of this study is to compare patients with knee osteoarthritis (OA) receiving optimized non-surgical treatment plus surgical realignment of the tibia, or optimized non-surgical treatment only. We hypothesize that outcomes assessed at 12 and 24 months follow-up will suggest favourable changes in patients undergoing surgical realignment when compared to patients receiving non-surgical treatment only.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Medial Opening Wedge High Tibial Osteotomy (HTO); Other: Non-Surgical Treatment Program

Detailed Description

This two groups, parallel design randomized controlled trial will compare patients with medial compartment knee OA and varus alignment receiving optimized non-surgical treatment plus High Tibial Osteotomy (HTO) to similar patients receiving optimized non-surgical treatment only. All participants will receive non-surgical treatment that will be individualized to the patient and include medications, physiotherapy and nutritional seminars. The non-surgical treatment will include supervised physiotherapy and nutritional seminars once per week for 12 weeks, will be accompanied and followed by a home program, and follow-up appointments for potential modification every three months for the duration of the study. Participants randomized to surgery will also undergo medial opening wedge HTO after 12 weeks of optimized non-surgical treatment. Both groups will follow the same schedule of clinic visits throughout the 24 month follow-up period. MRI-derived measures of articular cartilage morphology, biological markers of articular cartilage degradation and synthesis, gait biomechanics and patient-reported outcomes will be assessed at baseline, 12 and 24 months follow-up.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Fowler Kennedy Sport Medicine Clinic, Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Is the subject either:

   1. 25-55 years old?
   2. Older than 55 but still active (ex. physical labour, regular recreational activities)?
2. Does this subject present with varus alignment? (Based on hip to ankle x-rays).
3. 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?
4. 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.

Exclusion Criteria:

1. Has this subject had a previous HTO or joint replacement in either limb?
2. Is this subject likely to undergo bilateral HTO within the 2 year follow up period?
3. Does this subject have an unstable knee or ligament?
4. Does this subject have inflammatory or infectious arthritis of the knee?
5. Radiographic disease too advanced for HTO (ie. diffuse lateral compartment, patellofemoral joint OA and/or severe enough disease to suggest that joint replacement is the better surgical option) and/or Kellgren and Lawrence grade 4.
6. The subject's disease is not advanced enough (symptomatically or radiographically) to warrant HTO.
7. Does this subject have a major medical illness with life expectancy <2 years or with an unacceptably high operative risk?
8. Does this subject have a major neurological deficit that would affect gait?
9. Is this subject possibly pregnant or planning pregnancy?
10. Is this subject unable to read English?
11. Does this subject have a psychiatric illness that limits informed consent?
12. Is the subject unlikely to comply with study protocol?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Surgical Treatment plus HTO; 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.	Procedure: Medial Opening Wedge High Tibial Osteotomy (HTO); A lower limb realignment surgery to redistribute load away from the most affected portion of the knee.; Other: Non-Surgical Treatment Program; A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.
Active Comparator: Non-Surgical Treatment; 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.	Other: Non-Surgical Treatment Program; A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI articular cartilage morphology	3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness	Change from baseline to 24 months post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient-reported outcome measure. 5 subdomains: pain, symptoms, activities of daily living, sport and recreation, quality of life	Change from baseline to 24 months post operative
Western Ontario Meniscal Evaluation Tool (WOMET)	Patient-reported outcome measure. Assesses health-related quality of life (HRQoL) in patients with meniscal tears. 3 dimensions: physical symptoms, sports/recreation/work/lifestyle, emotions	Change from baseline to 24 months post operative
Biological Markers of Disease Progression	Synovial fluid, serum and urine biological markers	Baseline, 12 and 24 months post operative
Numeric Rating Scale for Pain	Patient-reported outcome measure. Assesses patient's pain. 0 (no pain) - 10 (worst possible pain)	Baseline, 12 and 24 months post operative
Gait Biomechanics	Knee frontal, sagittal and transverse plane kinematics and kinetics tested during level walking in a motion analysis laboratory. The measure of most interest is the peak external knee adduction moment during stance phase of walking.	Baseline, 12 and 24 months post operative
Isometric Strength Testing	Isometric quadriceps and hamstrings strength tested using an isokinetic dynamometer.	Baseline, 12 and 24 months post operative
Intermittent and Constant Osteoarthritis Pain Index (ICOAP)	Patient-reported outcome measure. Assesses pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain. 3 domains: intermittent pain, constant pain, total pain	Change from baseline to 24 months post operative
Short-Form 12 (SF12)	Patient-reported outcome measure. Self-reported outcome measure assessing the impact of health on an individual's everyday life	Change from baseline to 24 months post operative
Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Patient-reported outcome measure. 3 sub domains: pain, symptoms, function	Change from baseline to 24 months post operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness questionnaires	Collection of accumulated direct and indirect costs related to the intervention incurred over the study period as reported by the patient.	Baseline and every 3 months from baseline up to 24 months post operative

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: Canadian Institutes of Health Research (CIHR); The Arthritis Society, Canada
• Investigators: Principal Investigator: Trevor B Birmingham, PT, PhD, Western University; Principal Investigator: J R Giffin, MD, Western University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2014
• Primary Completion (Actual): April 18, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimated): December 6, 2013

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: knee osteoarthritis; magnetic resonance imaging; body composition; biological markers; gait analysis; muscular strength; high tibial osteotomy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: TAS-SOG-13-020; MOP-133489 (Other Grant/Funding Number: CIHR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO