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Reducing Recurrent Knee Flexion Contracture by Correcting Leg Length Discrepancy After Total Knee Arthroplasty for OA

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ClinicalTrials.gov Identifier: NCT02861521
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
Moving one's joints through their full range of motion (ROM) is crucial for health and wellbeing. Those who are unable to do so have difficulty carrying out simple activities like walking or feeding themselves. Lost joint ROM is called a contracture. Osteoarthritis (OA) is the most common form of arthritis. About a third of people with knee OA develop knee flexion contractures (KFlCs), the inability to fully straighten the knee. Having a KFlC before a knee replacement is a big risk factor for redeveloping one after the operation. Many people with a KFlC in the knee for surgery also have a KFlC in the other knee. The investigators believe that this non-surgical KFlC increases the risk of re-developing a KFlC in the surgical knee after surgery by encouraging bending of the surgical knee to avoid one leg being shorter than the other. No one has ever looked at whether fixing this leg length difference using a shoe lift would prevent this problem and there is little information to help design such a study. Here the investigators will see if testing shoe lift use for preventing KFlC is feasible. The investigators hypothesis is that a study evaluating the benefit of using a shoe lift to correct leg length difference in the non-surgical knee is feasible.

Condition or disease Intervention/treatment Phase
Osteoarthritis Contracture Device: Shoe lift Device: Sham Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Postoperative Knee Flexion Contracture Recurrence by Correcting Leg Length Discrepancy in the Non-surgical Knee in Patients Undergoing Total Knee Arthroplasty for Primary Osteoarthritis: A Feasibility Study
Study Start Date : August 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Corrective shoe lift
Participants will be given an external shoe lift to correct post-operative leg length discrepancy (LLD).
Device: Shoe lift
Subjects will be given a shoe lift post-knee replacement to correct leg length discrepancy

Sham Comparator: Sham shoe intervention
Participants will be given a sham shoe intervention that does not correct post-operative leg length discrepancy.
Device: Sham
Sham shoe modification




Primary Outcome Measures :
  1. Pain assessed by visual analogue scale [ Time Frame: 3 months post-knee replacement ]
    Pain assessed by visual analogue scale

  2. Pain assessed by visual analogue scale [ Time Frame: 6 months post-knee replacement ]
  3. Pain assessed by visual analogue scale [ Time Frame: 12 months post-knee replacement ]
  4. Pain assessed by visual analogue scale [ Time Frame: 24 months post-knee replacement ]
  5. Pain assessed by pain subscales of Knee injury and Osteoarthritis Outcome Score (KOOS) and The Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 3 months post-knee replacement ]
    Pain assessed by pain subscales of KOOS and WOMAC.

  6. Pain assessed by pain subscales of KOOS and WOMAC. [ Time Frame: 6 months post-knee replacement ]
  7. Pain assessed by pain subscales of KOOS and WOMAC. [ Time Frame: 12 months post-knee replacement ]
  8. Pain assessed by pain subscales of KOOS and WOMAC. [ Time Frame: 24 months post-knee replacement ]
  9. Function assessed by function subscales of KOOS and WOMAC. [ Time Frame: 3 months post-knee replacement ]
    Function assessed by function subscales of KOOS and WOMAC.

  10. Function assessed by function subscales of KOOS and WOMAC. [ Time Frame: 6 months post-knee replacement ]
    Function assessed by function subscales of KOOS and WOMAC.

  11. Function assessed by function subscales of KOOS and WOMAC. [ Time Frame: 12 months post-knee replacement ]
    Function assessed by function subscales of KOOS and WOMAC.

  12. Function assessed by function subscales of KOOS and WOMAC. [ Time Frame: 24 months post-knee replacement ]
    Function assessed by function subscales of KOOS and WOMAC.


Secondary Outcome Measures :
  1. Bilateral knee range of motion measured using goniometer. [ Time Frame: 3 months post-knee replacement ]
    Measured using goniometer

  2. Bilateral knee range of motion measured using goniometer. [ Time Frame: 6 months post-knee replacement ]
    Measured using goniometer

  3. Bilateral knee range of motion measured using goniometer. [ Time Frame: 12 months post-knee replacement ]
    Measured using goniometer

  4. Bilateral knee range of motion measured using goniometer. [ Time Frame: 24 months post-knee replacement ]
    Measured using goniometer

  5. 6-minute walk test [ Time Frame: 3 months post-knee replacement ]
    6-minute walk test

  6. 6-minute walk test [ Time Frame: 6 months post-knee replacement ]
    6-minute walk test

  7. 6-minute walk test [ Time Frame: 12 months post-knee replacement ]
    6-minute walk test

  8. 6-minute walk test [ Time Frame: 24 months post-knee replacement ]
    6-minute walk test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for unilateral TKA for 1° OA will be assessed for eligibility. Those meeting the American College of Rheumatology criteria for knee OA and having bilateral knee flexion contractures (KFlCs) will be recruited. KFlC will be defined as a loss of knee extension of 6 or more degrees.

Exclusion Criteria:

  • Exclusion criteria include TKA for cause other than primary OA, previous septic arthritis, history of inflammatory arthritis, previous condition or known connective tissue disease that is known to affect joint range of motion.

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): NCT02861521


Contacts
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Contact: T Mark Campbell, MD MSc FRCPC 1-613-562-6262 ext 4064 tcampbell@bruyere.org
Contact: Katherine Reilly, MSc 1-613-562-5800 ext 8238 kreilly011@gmail.com

Locations
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Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Katherine Reilly, MSc         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: T Mark Campbell, MD MSc FRCPC University of Ottawa
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02861521    
Other Study ID Numbers: 20160109-01H
M16-16-033 ( Other Grant/Funding Number: Elisabeth Bruyere Academic Medical Organizaton )
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be reported in aggregate.
Additional relevant MeSH terms:
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Osteoarthritis
Contracture
Leg Length Inequality
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Muscular Diseases
Bone Diseases, Developmental
Bone Diseases
Pathological Conditions, Anatomical