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

NCT ID: NCT02003976

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-05
• Study Completion Date: 2023-04-26

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Medial Opening Wedge High Tibial Osteotomy (HTO)

Intervention Type: PROCEDURE

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

Non-Surgical Treatment Program

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Non-Surgical Treatment Program

Intervention Type: OTHER

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

Interventions

Medial Opening Wedge High Tibial Osteotomy (HTO)

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

Intervention Type: PROCEDURE

Non-Surgical Treatment Program

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

Intervention Type: OTHER

Eligibility Criteria

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?

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Arthritis Society, Canada

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Trevor Birmingham

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trevor B Birmingham, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

J R Giffin, MD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Fowler Kennedy Sport Medicine Clinic, Western University

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 40720836 (View on PubMed)

Other Identifiers

MOP-133489

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TAS-SOG-13-020

Identifier Type: -

Identifier Source: org_study_id