Joint Disease
Conditions
Keywords
osteoarthritis, correction of functional deformity, procedures, traumatic osteoarthritis, degenerative osteoarthritis, total knee arthroplasty, Healthy Volunteers, electromyography, Musculoskeletal Diseases
Brief summary
MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous study which showed the Medial Pivot (MP) system required lower quadriceps activation than subjects implanted with a Posterior stabilized (PS) system preforming the same activities of daily living.
Detailed description
MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous study which showed the Medial Pivot (MP) system required lower quadriceps activation than subjects implanted with a Posterior stabilized (PS) system preforming the same activities of daily living. The propose of the current study is to determine the impact of Total Knee Arthroplasty (TKA) design on muscle activation following TKA surgery.
Interventions
DEVICEGroup 1 (Medial-Pivot)
EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts
DEVICEGroup 2 (Posterior-Stabilized)
Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts
Sponsors
University of Ottawa
The Ottawa Hospital
MicroPort Orthopedics Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 76 Years
Healthy volunteers
Yes
Inclusion criteria
To be included in Groups 1 and 2, subjects must meet all of the following criteria: Subject is a candidate for unilateral primary TKA for degenerative or traumatic osteoarthritis Subject is a candidate to be implanted with the specified combination of components for either Group 1 or 2 Subjects are at least 45 years old and less than 76 years of age at time of enrollment Subject is willing and able to complete required study visits and assessments Subject plans to be available through the 1 year postoperative follow-up visit Subject is willing to sign the approved Informed Consent document To be included in Group 3, subjects must meet all of the following criteria: Subjects are at least 45 years old and less than 76 years of age at time of enrollment Subject is willing and able to complete required study visit and assessments Subject is willing to sign the approved Informed Consent document
Exclusion criteria
Subjects will be excluded if they meet any of the following criteria: Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0 kg/m2 and 102.0 cm respectively for men and 35.0 kg/m2 and 88.0 cm respectively for women at screening. Groups 1 & 2 Only: Subject has degenerative conditions (other than osteoarthritis in the enrolled TKA) impacting joints of the lower extremities, previous joint replacement of the enrolled knee or other lower limb joint replacement, or any other past or present condition, which in the opinion of the Investigator may impact gait. Group 3 Only: Subject has degenerative condition impacting joints of the lower extremities, any previous joint replacement in the knees, or any other past or present condition, which in the opinion of the Investigator may impact gait. Groups 1 and 2 Only: Subjects with a Kellgren-Lawrence Grading Scale of ≥2 on the contralateral knee if having severe pain or abnormal gait patterns. Subject is currently enrolled in another clinical investigation related to lower limbs which could affect the endpoints of this protocol. Subject is unwilling or unable to sign the Informed Consent document Subject has documented substance abuse issues Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study Subject is currently incarcerated or has impending incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower Limb Muscle Activation Comparison as Assessed by Maximum Voluntary Isometric Contraction Muscle Strength and Dynamic Muscle Activation Measurements in Total Knee Arthroplasty Subjects Implanted with Medial-pivot or Posterior-stabilized Implants | Presurgery and 12 Months Post Surgery | Measured by Dynamic Muscle Activation Measurements and Maximum Voluntary Isometric Contraction Muscle Strength and Activation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare functional outcomes for the Groups 1 and 2 as assessed by the KOOS Scores | Presurgery and 12 Months Post Surgery for implanted subjects | Measured by KOOS Scores |
| Compare lower limb muscle activation between the control group (Group 3) and Groups 1 and 2, as assessed by maximum voluntary isometric contraction muscled strength and dynamic muscle activation measurements | Presurgery and 12 Months Post Surgery for implanted subjects | Measured by Dynamic Muscle Activation Measurements and Maximum Voluntary Isometric Contraction Muscle Strength and Activation |
| Compare functional outcomes for the Groups 1 and 2 as assessed by the Timed Up & Go (TUG) test | Presurgery and 12 Months Post Surgery for implanted subjects | Measured by Timed Up & Go (TUG) test |
| Compare subject satisfaction using a custom five question patient satisfaction questionnaire for Groups 1 and 2 | 12 Months Post Surgery | Measured by Patient Satisfaction Survey |
Countries
Canada
Outcome results
None listed