Clinical trial NCT02589197: Gait and Functional Outcomes Study Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants
Official title: Muscle Activation and Biomechanical Function of the Lower-limb Joints Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants: an Electromyography Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Joint Disease
Keywords: osteoarthritis
correction of functional deformity
procedures
traumatic osteoarthritis
degenerative osteoarthritis
total knee arthroplasty
Healthy Volunteers
electromyography
Musculoskeletal Diseases
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Ottawa
name: The Ottawa Hospital
First posted: 2015-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from the orthopedic clinic at The Ottawa hospital for implanted patients. Non-implanted subjects will be selected from the community.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Presurgery and 12 Months Post Surgery
Secondary outcomes:
measure: 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
timeFrame: Presurgery and 12 Months Post Surgery for implanted subjects
measure: Compare functional outcomes for the Groups 1 and 2 as assessed by the Timed Up & Go (TUG) test
timeFrame: Presurgery and 12 Months Post Surgery for implanted subjects
measure: Compare functional outcomes for the Groups 1 and 2 as assessed by the KOOS Scores
timeFrame: Presurgery and 12 Months Post Surgery for implanted subjects
measure: Compare subject satisfaction using a custom five question patient satisfaction questionnaire for Groups 1 and 2
timeFrame: 12 Months Post Surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: Ottawa Hospital
name: Geoffrey Dervin, MD
role: PRINCIPAL_INVESTIGATOR
References: