Knee OsteoarthritisNCT02003976

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

A study testing Medial Opening Wedge High Tibial Osteotomy (HTO) and Non-Surgical Treatment Program in people with Knee Osteoarthritis, run by Western University, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 55 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Medial Opening Wedge High Tibial Osteotomy (HTO) and Non-Surgical Treatment Program
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteCanada
Study dates: 5 Sep 2014to 26 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Is the subject either:
25-55 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.

Who cannot join

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.

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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?

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

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.

Read the 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.

Conditions: Knee Osteoarthritis
Being tested: Medial Opening Wedge High Tibial Osteotomy (HTO), Non-Surgical Treatment Program
Keywords: knee osteoarthritis, high tibial osteotomy, gait analysis, muscular strength, body composition, magnetic resonance imaging, biological markers
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medial Opening Wedge High Tibial Osteotomy (HTO)Procedure or surgery
A lower limb realignment surgery to redistribute load away from the most affected portion of the knee.
Non-Surgical Treatment ProgramOther
A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.

Study groups in NCT02003976
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Non-Surgical Treatment Program

What is being measured

The primary outcome is the main question the study is designed to answer.

MRI articular cartilage morphology
3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness
Measured: Change from baseline to 24 months post operative

Secondary outcomes (9)

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
Measured: 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
Measured: Change from baseline to 24 months post operative
Biological Markers of Disease Progression
Synovial fluid, serum and urine biological markers
Measured: 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)
Measured: 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.
Measured: Baseline, 12 and 24 months post operative
Isometric Strength Testing
Isometric quadriceps and hamstrings strength tested using an isokinetic dynamometer.
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline to 24 months post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201426 Apr 2023

First posted6 Dec 2013 (estimated)
Study start5 Sep 2014
Primary completion18 Apr 2023
Study completion26 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02003976
Sponsor's protocol ID: TAS-SOG-13-020
Other IDs: MOP-133489
Status last verified: Jul 2024
First submitted: 2 Dec 2013
Last updated: 24 Jul 2024
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 40720836

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
ClinicalTrials.gov ID: NCT02003976
Acronym / sponsor ID: TAS-SOG-13-020
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis, high tibial osteotomy, gait analysis, muscular strength, body composition, magnetic resonance imaging, biological markers
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Western University, CanadaUniversity, hospital or other
Collaborators: The Arthritis Society, Canada, Canadian Institutes of Health Research (CIHR)
Study start: 5 Sep 2014 (actual)
Primary completion: 18 Apr 2023 (actual)
Study completion: 26 Apr 2023 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Non-Surgical Treatment plus HTO	Experimental	Procedure: Medial Opening Wedge High Tibial Osteotomy (HTO), Other: Non-Surgical Treatment ProgramThe 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.
Non-Surgical Treatment	Active comparator	Other: Non-Surgical Treatment ProgramThe 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.

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Is the subject either:
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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medial Opening Wedge High Tibial Osteotomy (HTO)A lower limb realignment surgery to redistribute load away from the most affected portion of the knee.	Procedure or surgery	Non-Surgical Treatment plus HTO
Non-Surgical Treatment ProgramA 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.	Other	Non-Surgical Treatment, Non-Surgical Treatment plus HTO

Primary outcome

MRI articular cartilage morphology
Time frame: Change from baseline to 24 months post operative
3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness

9 secondary outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Change from baseline to 24 months post operative
Western Ontario Meniscal Evaluation Tool (WOMET)
Time frame: Change from baseline to 24 months post operative
Biological Markers of Disease Progression
Time frame: Baseline, 12 and 24 months post operative
Numeric Rating Scale for Pain
Time frame: Baseline, 12 and 24 months post operative
Gait Biomechanics
Time frame: Baseline, 12 and 24 months post operative
Isometric Strength Testing
Time frame: Baseline, 12 and 24 months post operative
Intermittent and Constant Osteoarthritis Pain Index (ICOAP)
Time frame: Change from baseline to 24 months post operative
Short-Form 12 (SF12)
Time frame: Change from baseline to 24 months post operative
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Change from baseline to 24 months post operative

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Derived from this study: PubMed 40720836Birmingham 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.
Individual participant dataSharing planned: No

Related trials for Knee Osteoarthritis

Recruiting
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Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Trevor B Birmingham, PT, PhD principal investigator

Western University

J R Giffin, MD principal investigator

Western University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medial Opening Wedge High Tibial Osteotomy (HTO) and Non-Surgical Treatment Program in people with Knee Osteoarthritis, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI articular cartilage morphology (time frame: Change from baseline to 24 months post operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02003976, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.