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

NCT ID: NCT02589197

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-13
• Study Completion Date: 2022-09-30

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.

Conditions

Joint Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 (Medial-Pivot)

Group 1 will be implanted with the EVOLUTION® MP System with Cruciate Sacrificing (CS) tibial inserts.

Group 1 (Medial-Pivot)

Intervention Type: DEVICE

EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts

Group 2 (Posterior-Stabilized)

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

Group 2 (Posterior-Stabilized)

Intervention Type: DEVICE

Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts

Group 3 (Control Group)

Non-implanted control subjects

No interventions assigned to this group

Interventions

Group 1 (Medial-Pivot)

EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts

Intervention Type: DEVICE

Group 2 (Posterior-Stabilized)

Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts

Intervention Type: DEVICE

Other Intervention Names

EVOLUTION® CS TKA System; Total Knee Arthroplasty Sytem; EVOLUTION®; Zimmer® NexGen® PS TKA System; Total Knee Arthroplasty Sytem; NexGen®

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ottawa

OTHER

Sponsor Role: collaborator

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey Dervin, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

University of Ottawa

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 40602029 (View on PubMed)

Other Identifiers

15-LJK-001

Identifier Type: -

Identifier Source: org_study_id