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

NCT02589197 | Completed

• 1 other identifier: 15-LJK-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Joint Disease

Keywords

osteoarthritis; correction of functional deformity; procedures; traumatic osteoarthritis; degenerative osteoarthritis; total knee arthroplasty; Healthy Volunteers; electromyography; Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• Compare functional outcomes for the Groups 1 and 2 as assessed by the 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

  12 Months Post Surgery

Study Arms (3)

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)

Group 2 (Posterior-Stabilized)

Group 2 will be implanted with the Zimmer® NexGen® PS TKA system.

Device: Group 2 (Posterior-Stabilized)

Group 3 (Control Group)

Non-implanted control subjects

Interventions

Group 1 (Medial-Pivot) DEVICE

EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts

Also known as: EVOLUTION® CS TKA System, Total Knee Arthroplasty Sytem, EVOLUTION®

Group 1 (Medial-Pivot)

Group 2 (Posterior-Stabilized) DEVICE

Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts

Also known as: Zimmer® NexGen® PS TKA System, Total Knee Arthroplasty Sytem, NexGen®

Group 2 (Posterior-Stabilized)

Eligibility Criteria

• Age: 45 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead
• University of Ottawa: collaborator
• The Ottawa Hospital: collaborator

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

University of Ottawa

Ottawa, Ontario, Canada

Location

Related Publications (1)

• Kowalski E, Catelli DS, Pelegrinelli ARM, Dervin G, Lamontagne M. EFORT Michael Freeman Award 2020: Knee biomechanics before and after total knee arthroplasty with either a medial pivot or posterior stabilized implants. Clin Biomech (Bristol). 2025 Jul;127:106604. doi: 10.1016/j.clinbiomech.2025.106604. Epub 2025 Jun 26.

  PMID: 40602029 DERIVED

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Arthritis; Rheumatic Diseases

Study Officials

• Geoffrey Dervin, MD

  Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 28, 2015
• Study Start: July 13, 2016
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)