Clinical trial NCT03681977: Clinical Outcomes of MP Persona vs. Persona Knee-PS
Official title: The Influence of Medial Pivot Knee Arthroplasty Implant Design on Joint Mechanics, Muscle Activation and Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Total Knee Arthroplasty
Medial Pivot Knee Implant Design
Knee Joint Mechanics
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: Jewish General Hospital
name: McGill University
name: Zimmer Biomet
name: Montreal General Hospital
First posted: 2018-09-24
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, double-blinded, randomized control study consisting of a clinical follow-up followed by a knee kinematics assessment. Patients outcomes will be measured pre-operatively, and at 1 and 2 years post-surgery. 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Knee mechanics
timeFrame: pre-operative (as baseline) and at 1 and 2 years following TKA
Secondary outcomes:
measure: Muscle activation
timeFrame: pre-operative (as baseline) and at 1 and 2 years following TKA
measure: The 30 seconds Chair Test - Physical Function Performance Test
timeFrame: at 1 and 2 years following TKA
measure: The Stair Climb Test - Physical Function Performance Test
timeFrame: at 1 and 2 years following TKA
measure: The 6 Minutes Walk Test - Physical Function Performance Test
timeFrame: at 1 and 2 years following TKA
measure: Knee Osteoarthritis and Outcome Score (KOOS) Self-Evaluation Questionnaire for Implant Performance
timeFrame: pre-operative (as baseline) and at 1 and 2 years following TKA
measure: EQ-5D-5L Self-Evaluation Questionnaire for Implant Performance
timeFrame: pre-operative (as baseline) and at 1 and 2 years following TKA
measure: Global Rating of Change (GRC) Self-Evaluation Questionnaire for Implant Performance
timeFrame: pre-operative (as baseline) and at 1 and 2 years following TKA
measure: Sensitivity to Physical Activity
timeFrame: at 1 and 2 years following TKA
measure: Radiographs
timeFrame: pre-operatively, intra operatively and at 6 weeks, 1 year and 2 years post-operatively
measure: Adverse Events
timeFrame: intra operatively and at 6 weeks, 1 year and 2 years post-operatively
Other outcomes:
measure: Maximum Voluntary Isometric Contractions (MVIC)
timeFrame: pre-operative (as baseline) and at 1 and 2 years following TKA
Locations:
city: Montréal
country: Canada
facility: Montreal General Hospital
state: PQ
city: Montréal
country: Canada
facility: Lethbridge-Layton-MacKay Rehabilitation Centre
state: PQ
city: Montréal
country: Canada
facility: Jewish General Hospital
state: PQ
Study officials:
affiliation: Jewish General Hospital
name: John Antoniou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: