The Influence of Medial Pivot Knee Arthroplasty Implant Design on Joint Mechanics, Muscle Activation and Clinical Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Lady Davis Institute
- Enrollment
- 162
- Locations
- 3
- Primary Endpoint
- Knee mechanics
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
Knee osteoarthritis (OA) is a highly prevalent condition that results in substantial pain and loss of function. The end stage treatment for knee OA is total knee arthroplasty (TKA), a common and safe procedure typically performed for relief of symptoms. However, an increasing number of patients are complaining about their TKA due to altered sensations between their previous joint and the implant. Although several designs have been proposed to improve these outcomes, the knee kinematics after TKA remains different from physiological kinematics. The Medial Pivot TKA design was introduced to closely mimic normal knee kinematics and create the natural feeling of the knee. This study is intended to evaluate the clinical effectiveness and ability to restore knee motion of two TKA devices: the Medial Pivot Persona TKA Zimmer design with the traditional Zimmer Persona Knee-PS. The investigator's hypothesis is that the Medial Pivot design will results in better patient outcomes and restore knee motion at natural parameters.
Detailed Description
This is a prospective, double-blinded, randomized control study comparing the TKA Zimmer Medial Pivot Persona design to the traditional Zimmer Persona Knee-PS. Eighty patients requiring a TKA will be recruited and randomized to one of the two treatment arms following confirmation of eligibility criteria. Forty age and sex matched healthy participants with no knee OA will also be recruited to provide a comparator measure of "normal" joint motion. Clinical follow-up visits and radiographic assessments will be performed pre- and post-operative at 6-weeks, 1-year, 2-years. Knee kinematics and self-assessment will be completed at the following intervals: pre-operative as baseline assessments for knee motion, 1-year, 2-years. Measures will include joint mechanics and neuromuscular activation during walking and stair stepping measured with motion capture and electromyography, and clinical/self assessment including pain in response to physical activity. Any other adverse events and complications (i.e, implant failure, re-operation, infection) will be record throughout the study. Healthy participants will only be assessed once to provide normative data.
Investigators
John Antoniou, MD PhD
Principal Investigator, Research Director of the Division of Orthopaedic Surgery McGill University, Profesor of Surgery McGill University.
Lady Davis Institute
Eligibility Criteria
Inclusion Criteria
- •Individuals diagnosed with osteoarthritis, who in the opinion of the investigator, are suitable candidates for primary total knee replacement using the devices specified in the protocol;
- •Males and females between 18 - 80 years at the time of surgery;
- •Individuals who understand the conditions of the study and are willing and able to provide informed consent for participation in the study;
- •Individuals who are willing and able to participate for the length of the prescribed term of follow-up;
- •Individuals who are willing and able to complete all the assessments specified by the study protocol.
Exclusion Criteria
- •The presence of previous failed lower extremity arthroplasty or metalwork in situ;
- •Patients with severe hip osteoarthritis;
- •Patients with lower extremity trauma requiring surgery within 1 year;
- •Patients with inflammatory arthritis, severe neurological conditions, or severe cardiovascular conditions.
Outcomes
Primary Outcomes
Knee mechanics
Time Frame: pre-operative (as baseline) and at 1 and 2 years following TKA
nee motion will be assessed using 3-dimensional optical motion capture sampled at 100 Hz, floor and step mounted force plates sampled at 2000 Hz, and wireless 16-channel electromyography (EMG) system sampled at 2000 Hz. Knee motion trials will require participants to ambulate at self-selected speeds over 8 meters followed by complete step up/down trials on a 20 cm step. For step up, the surgical limb will be placed on the step to start while for step down, both limbs will start on the step. The order of step up and down trials will be randomized. Participants will perform 2 practice trials followed by testing. Testing will proceed until 5 successful trials of each activity are collected. They will be allowed 30 seconds of rest between trials. The primary motion capture variables will include principal component scores that capture changes in range of motion for knee rotation and flexion angles for each activity.
Secondary Outcomes
- The 30 seconds Chair Test - Physical Function Performance Test(at 1 and 2 years following TKA)
- Knee Osteoarthritis and Outcome Score (KOOS) Self-Evaluation Questionnaire for Implant Performance(pre-operative (as baseline) and at 1 and 2 years following TKA)
- Global Rating of Change (GRC) Self-Evaluation Questionnaire for Implant Performance(pre-operative (as baseline) and at 1 and 2 years following TKA)
- The 6 Minutes Walk Test - Physical Function Performance Test(at 1 and 2 years following TKA)
- EQ-5D-5L Self-Evaluation Questionnaire for Implant Performance(pre-operative (as baseline) and at 1 and 2 years following TKA)
- Radiographs(pre-operatively, intra operatively and at 6 weeks, 1 year and 2 years post-operatively)
- Adverse Events(intra operatively and at 6 weeks, 1 year and 2 years post-operatively)
- Muscle activation(pre-operative (as baseline) and at 1 and 2 years following TKA)
- The Stair Climb Test - Physical Function Performance Test(at 1 and 2 years following TKA)
- Sensitivity to Physical Activity(at 1 and 2 years following TKA)