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

NCT02003976 | Completed DMC

• 2 other identifiers: TAS-SOG-13-020MOP-133489
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; high tibial osteotomy; gait analysis; muscular strength; body composition; magnetic resonance imaging; biological markers

Outcome Measures

Primary Outcomes (1)

• MRI articular cartilage morphology

  3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness

  Change from baseline to 24 months post operative

Secondary Outcomes (9)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Change from baseline to 24 months post operative

• Western Ontario Meniscal Evaluation Tool (WOMET)

  Change from baseline to 24 months post operative

• Biological Markers of Disease Progression

  Baseline, 12 and 24 months post operative

• Numeric Rating Scale for Pain

  Baseline, 12 and 24 months post operative

• Gait Biomechanics

  Baseline, 12 and 24 months post operative

Other Outcomes (1)

• Cost-effectiveness questionnaires

  Baseline and every 3 months from baseline up to 24 months post operative

Study Arms (2)

Non-Surgical Treatment plus HTO

EXPERIMENTAL

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); Other: Non-Surgical Treatment Program

Non-Surgical Treatment

ACTIVE COMPARATOR

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

Interventions

Medial Opening Wedge High Tibial Osteotomy (HTO) PROCEDURE

A lower limb realignment surgery to redistribute load away from the most affected portion of the knee.

Non-Surgical Treatment plus HTO

Non-Surgical Treatment Program OTHER

A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.

Non-Surgical Treatment; Non-Surgical Treatment plus HTO

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is the subject either:
• years old?
• Older than 55 but still active (ex. physical labour, regular recreational activities)?
• Does this subject present with varus alignment? (Based on hip to ankle x-rays).
• 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.

You may not qualify if:

• Has this subject had a previous HTO or joint replacement in either limb?
• Is this subject likely to undergo bilateral HTO within the 2 year follow up period?
• Does this subject have an unstable knee or ligament?
• Does this subject have inflammatory or infectious arthritis of the knee?
• 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.
• The subject's disease is not advanced enough (symptomatically or radiographically) to warrant HTO.
• Does this subject have a major medical illness with life expectancy \<2 years or with an unacceptably high operative risk?
• Does this subject have a major neurological deficit that would affect gait?
• Is this subject possibly pregnant or planning pregnancy?
• Is this subject unable to read English?
• Does this subject have a psychiatric illness that limits informed consent?
• Is the subject unlikely to comply with study protocol?

Sponsors & Collaborators

• Western University, Canada: lead
• The Arthritis Society, Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic, Western University

London, Ontario, N6A 3K7, Canada

Location

Related Publications (1)

• Birmingham TB, Primeau CA, Moyer RF, Bryant DM, Ma J, Leitch KM, Wirth W, Degen R, Getgood AM, Litchfield RB, Willits KR, Eckstein F, Giffin JR. High Tibial Osteotomy for Medial Compartment Knee Osteoarthritis : A Randomized Trial With Parallel Preference Arm. Ann Intern Med. 2025 Sep;178(9):1238-1248. doi: 10.7326/ANNALS-25-00920. Epub 2025 Jul 29.

  PMID: 40720836 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Trevor B Birmingham, PT, PhD

  Western University

  PRINCIPAL INVESTIGATOR

• J R Giffin, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: September 5, 2014
• Primary Completion: April 18, 2023
• Study Completion: April 26, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)