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

NCT02861521 | Completed

• 2 other identifiers: 20160109-01HM16-16-033
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Contracture

Outcome Measures

Primary Outcomes (14)

• Pain assessed by visual analogue scale

  Pain assessed by visual analogue scale

  Baseline (pre-op recruitment)

• Pain assessed by visual analogue scale

  Pain assessed by visual analogue scale

  3 months post-knee replacement

• Pain assessed by visual analogue scale

  6 months post-knee replacement

• Pain assessed by visual analogue scale

  12 months post-knee replacement

• Pain assessed by visual analogue scale

  24 months post-knee replacement

• Pain assessed by pain subscales of Knee injury and Osteoarthritis Outcome Score (KOOS) and The Western Ontario and McMaster Universities Arthritis Index (WOMAC).

  Pain assessed by pain subscales of KOOS and WOMAC.

  Baseline (pre-op recruitment)

• Pain assessed by pain subscales of Knee injury and Osteoarthritis Outcome Score (KOOS) and The Western Ontario and McMaster Universities Arthritis Index (WOMAC).

  Pain assessed by pain subscales of KOOS and WOMAC.

  3 months post-knee replacement

• Pain assessed by pain subscales of KOOS and WOMAC.

  6 months post-knee replacement

• Pain assessed by pain subscales of KOOS and WOMAC.

  12 months post-knee replacement

• Pain assessed by pain subscales of KOOS and WOMAC.

  24 months post-knee replacement

• Function assessed by function subscales of KOOS and WOMAC.

  Function assessed by function subscales of KOOS and WOMAC.

  3 months post-knee replacement

• Function assessed by function subscales of KOOS and WOMAC.

  Function assessed by function subscales of KOOS and WOMAC.

  6 months post-knee replacement

• Function assessed by function subscales of KOOS and WOMAC.

  Function assessed by function subscales of KOOS and WOMAC.

  12 months post-knee replacement

• Function assessed by function subscales of KOOS and WOMAC.

  Function assessed by function subscales of KOOS and WOMAC.

  24 months post-knee replacement

Secondary Outcomes (14)

• Bilateral knee range of motion measured using goniometer.

  Baseline (pre-op recruitment)

• Bilateral knee range of motion measured using goniometer.

  3 months post-knee replacement

• Bilateral knee range of motion measured using goniometer.

  6 months post-knee replacement

• Bilateral knee range of motion measured using goniometer.

  12 months post-knee replacement

• Bilateral knee range of motion measured using goniometer.

  24 months post-knee replacement

Study Arms (2)

Corrective shoe lift

EXPERIMENTAL

Participants will be given an external shoe lift to correct post-operative leg length discrepancy (LLD).

Device: Shoe lift

Sham shoe intervention

SHAM COMPARATOR

Participants will be given a sham shoe intervention that does not correct post-operative leg length discrepancy.

Device: Sham

Interventions

Shoe lift DEVICE

Subjects will be given a shoe lift post-knee replacement to correct leg length discrepancy

Corrective shoe lift

Sham DEVICE

Sham shoe modification

Sham shoe intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis; Contracture

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases

Study Officials

• T Mark Campbell, MD MSc FRCPC

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: August 10, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)