Gait and Functional Outcomes Study Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants (GOLD)

Muscle Activation and Biomechanical Function of the Lower-limb Joints Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants: an Electromyography Study

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.

Study Overview

• Status: Completed
• Conditions: Joint Disease
• Intervention / Treatment: Device: Group 1 (Medial-Pivot); Device: Group 2 (Posterior-Stabilized)

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Ottawa, Ontario, Canada
      • University of Ottawa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 76 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (Medial-Pivot); Group 1 will be implanted with the EVOLUTION® MP System with Cruciate Sacrificing (CS) tibial inserts.	Device: Group 1 (Medial-Pivot); EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts; Other Names: EVOLUTION® CS TKA System; Total Knee Arthroplasty Sytem; EVOLUTION®
Group 2 (Posterior-Stabilized); Group 2 will be implanted with the Zimmer® NexGen® PS TKA system.	Device: Group 2 (Posterior-Stabilized); Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts; Other Names: Total Knee Arthroplasty Sytem; Zimmer® NexGen® PS TKA System; NexGen®
Group 3 (Control Group); Non-implanted control subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured by Dynamic Muscle Activation Measurements and Maximum Voluntary Isometric Contraction Muscle Strength and Activation	Presurgery and 12 Months Post Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured by Dynamic Muscle Activation Measurements and Maximum Voluntary Isometric Contraction Muscle Strength and Activation	Presurgery and 12 Months Post Surgery for implanted subjects
Compare functional outcomes for the Groups 1 and 2 as assessed by the Timed Up & Go (TUG) test	Measured by Timed Up & Go (TUG) test	Presurgery and 12 Months Post Surgery for implanted subjects
Compare functional outcomes for the Groups 1 and 2 as assessed by the KOOS Scores	Measured by KOOS Scores	Presurgery and 12 Months Post Surgery for implanted subjects
Compare subject satisfaction using a custom five question patient satisfaction questionnaire for Groups 1 and 2	Measured by Patient Satisfaction Survey	12 Months Post Surgery

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Collaborators: The Ottawa Hospital; University of Ottawa
• Investigators: Principal Investigator: Geoffrey Dervin, MD, Ottawa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2016
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: osteoarthritis; Healthy Volunteers; total knee arthroplasty; Musculoskeletal Diseases; electromyography; correction of functional deformity; procedures; traumatic osteoarthritis; degenerative osteoarthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 15-LJK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO