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

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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

Tracking Information
First Submitted Date  ICMJE December 2, 2013
First Posted Date  ICMJE December 6, 2013
Last Update Posted Date October 8, 2020
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
MRI articular cartilage morphology [ Time Frame: Change from baseline to 24 months post operative ]
3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
  • 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
  • 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 ]
    Synovial fluid, serum and urine biological markers
  • Numeric Rating Scale for Pain [ Time Frame: Baseline, 12 and 24 months post operative ]
    0 (no pain) - 10 (worst possible pain)
  • 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.
  • Isometric Strength Testing [ Time Frame: Baseline, 12 and 24 months post operative ]
    Isometric quadriceps and hamstrings strength tested using an isokinetic dynamometer.
  • 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 ]
    3 sub domains: pain, symptoms, function
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
  • 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
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Change from baseline to 24 months post operative ]
    3 subdomains: pain, symptoms, function
  • Biological Markers of Disease Progression [ Time Frame: Baseline, 12 and 24 months post operative ]
    Synovial fluid, serum and urine biological markers
  • Numeric Rating Scale for Pain [ Time Frame: Baseline, 12 and 24 months post operative ]
    0 (no pain) - 10 (worst possible pain)
  • Gait Biomechanics [ Time Frame: Baseline, 12 and 24 months post operative ]
    Sagittal, frontal and transverse plane kinematics and kinetics
Current Other Pre-specified Outcome Measures
 (submitted: November 30, 2016)
Cost-effectiveness questionnaires [ Time Frame: Baseline and every 3 months from baseline up to 24 months post operative ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
Official Title  ICMJE A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Medial Opening Wedge High Tibial Osteotomy (HTO)
    • Other: Non-Surgical Treatment Program
  • 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.
    Intervention: Other: Non-Surgical Treatment Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2014)
72
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2013)
53
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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?
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominique Arsenault (519) 661-2111 ext 81122 darsena2@uwo.ca
Contact: Kristyn Leitch (519) 661-2111 ext 82744 kleitch@uwo.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02003976
Other Study ID Numbers  ICMJE TAS-SOG-13-020
MOP-133489 ( Other Grant/Funding Number: CIHR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Trevor Birmingham, Western University, Canada
Study Sponsor  ICMJE Western University, Canada
Collaborators  ICMJE
  • The Arthritis Society, Canada
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Trevor B Birmingham, PT, PhD Western University
Principal Investigator: J R Giffin, MD Western University
PRS Account Western University, Canada
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP