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Orthopedic Implant

TKA Implants for Osteoarthritis

N/A

Recruiting

Led By Isabelle Catelas, PhD, PEng

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls

Awards & highlights

Study Summary

This trial will compare the muscle function and quality, as well as the immune response to two different types of knee implants.

Eligible Conditions

Knee Inflammation
Osteoarthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline knee extension moment at 6 and 12 months during gait

Change from baseline muscle quality assessed via MRI at 12 months

Change from baseline quadriceps muscle activation at 6 and 12 months during gait

Secondary outcome measures

Change in trace metal concentrations from baseline, 12 months, and 24 months

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Implant GroupsExperimental Treatment2 Interventions

Group will receive the Smith & Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant

Group II: Healthy Control GroupActive Control1 Intervention

Control group that will not be undergoing a total knee arthroplasty

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of OttawaOTHER

205 Previous Clinical Trials

266,016 Total Patients Enrolled

4 Trials studying Osteoarthritis

582 Patients Enrolled for Osteoarthritis

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,616 Total Patients Enrolled

27 Trials studying Osteoarthritis

190,006 Patients Enrolled for Osteoarthritis

Isabelle Catelas, PhD, PEngPrincipal InvestigatorUniversity of Ottawa

Media Library

Smith & Nephew Journey II (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04105179 — N/A

Osteoarthritis Research Study Groups: Implant Groups, Healthy Control Group

Osteoarthritis Clinical Trial 2023: Smith & Nephew Journey II Highlights & Side Effects. Trial Name: NCT04105179 — N/A

Smith & Nephew Journey II (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04105179 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research project accept volunteers aged 30 and above?

"The maximum age for enrolment in this medical trial is 75, while the minimum entry point is 45."

Answered by AI

What is the projected size of enrollment for this clinical trial?

"Affirmative. According to details available on clinicaltrials.gov, this trial is currently recruiting participants after being initially posted April 29th 2019 and edited most recently August 5th 2022. 75 patients need to be recruited from one medical centre for the study's completion."

Answered by AI

Do I meet the criteria to be involved in this experiment?

"This research program is enrolling 75 individuals aged between 45 and 75 who suffer from knee osteoarthritis. To be eligible, participants must intend to receive a total knee implant replacement."

Answered by AI

Does this experiment currently require volunteer participants?

"Data from clinicaltrials.gov reveals that this medical investigation is actively searching for participants, having first been posted on April 29th 2019 and recently updated August 5th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04105179.