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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003976
Recruitment Status : Recruiting
First Posted : December 6, 2013
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
The Arthritis Society, Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Trevor Birmingham, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Medial Opening Wedge High Tibial Osteotomy (HTO) Other: Non-Surgical Treatment Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
Study Start Date : September 2014
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.




Primary Outcome Measures :
  1. MRI articular cartilage morphology [ Time Frame: Change from baseline to 24 months post operative ]
    3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness


Secondary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Change from baseline to 24 months post operative ]
    5 subdomains: pain, symptoms, activities of daily living, sport and recreation, quality of life

  2. Western Ontario Meniscal Evaluation Tool (WOMET) [ Time Frame: Change from baseline to 24 months post operative ]
  3. Biological Markers of Disease Progression [ Time Frame: Baseline, 12 and 24 months post operative ]
    Synovial fluid, serum and urine biological markers

  4. Numeric Rating Scale for Pain [ Time Frame: Baseline, 12 and 24 months post operative ]
    0 (no pain) - 10 (worst possible pain)

  5. Gait Biomechanics [ Time Frame: Baseline, 12 and 24 months post operative ]
    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, expressed in %BW*Ht.

  6. Isometric Strength Testing [ Time Frame: Baseline, 12 and 24 months post operative ]
    Isometric quadriceps and hamstrings strength tested using an isokinetic dynamometer.

  7. Intermittent and Constant Osteoarthritis Pain Index (ICOAP) [ Time Frame: Change from baseline to 24 months post operative ]
  8. Short-Form 12 (SF12) [ Time Frame: Change from baseline to 24 months post operative ]
  9. Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Change from baseline to 24 months post operative ]
    3 sub domains: pain, symptoms, function


Other Outcome Measures:
  1. Cost-effectiveness questionnaires [ Time Frame: Baseline and every 3 months from baseline up to 24 months post operative ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003976


Contacts
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Contact: Dominique Arsenault (519) 661-2111 ext 81122 darsena2@uwo.ca
Contact: Kristyn Leitch (519) 661-2111 ext 82744 kleitch@uwo.ca

Locations
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Canada, Ontario
Fowler Kennedy Sport Medicine Clinic, Western University Recruiting
London, Ontario, Canada, N6A 3K7
Contact: Dominque Arsenault    519-661-2111 ext 81122    darsena2@uwo.ca   
Contact: Codie Primeau    519-661-2111 ext 82676    cprimea@uwo.ca   
Principal Investigator: Trevor B Birmingham, PT, PhD         
Principal Investigator: J R Giffin, MD         
Sponsors and Collaborators
Western University, Canada
The Arthritis Society, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Trevor B Birmingham, PT, PhD Western University
Principal Investigator: J R Giffin, MD Western University
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Responsible Party: Trevor Birmingham, Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT02003976    
Other Study ID Numbers: TAS-SOG-13-020
MOP-133489 ( Other Grant/Funding Number: CIHR )
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Trevor Birmingham, Western University, Canada:
knee osteoarthritis
high tibial osteotomy
gait analysis
muscular strength
body composition
magnetic resonance imaging
biological markers
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases