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How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response

NCT04105179 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-08-08

No results posted yet for this study

Summary

This study compares two total knee replacement implants to asses muscle function and quality, and the immune response to the implants. 30 patients will receive the Smith and Nephew Journey II implant, while 30 patients will receive the Zimmer NexGen LPS-flex implant. 15 healthy controls will also be recruited and compared.

Conditions

  • Osteoarthritis, Knee
  • Inflammation Knees

Interventions

DEVICE

Zimmer NexGen LPS-Flex

Patients will be randomly assigned to 1 of 2 devices

DEVICE

Smith & Nephew Journey II

Patients will be randomly assigned to 1 of 2 devices

Sponsors & Collaborators

  • University of Ottawa

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Mario Lamontagne, PhD · University of Ottawa

  • Isabelle Catelas, PhD, PEng · University of Ottawa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-29
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04105179 on ClinicalTrials.gov