How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response
Do TKA Implant Designs Affect Muscle Mass Change and Muscle Activity During Activities of Daily Living as Well as the Patient Immunological Response
1 other identifier
interventional
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2018
CompletedStudy Start
First participant enrolled
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 8, 2022
August 1, 2022
4.6 years
September 13, 2018
August 5, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Change from baseline knee extension moment at 6 and 12 months during gait
Peak knee extension moment will be measured by combining three-dimensional images of movement with time, the knee extension will be calculated in degrees while the participant walks at their normal walking speed.
Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
Change from baseline muscle quality assessed via MRI at 12 months
Proton density fat fraction of the quadriceps and hamstrings muscles will be measured via MRI
Baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls
Change from baseline quadriceps muscle activation at 6 and 12 months during gait
Peak muscle activation of the quadriceps muscle will be measured with electromyography while the participant walks at their normal walking speed
Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
Secondary Outcomes (1)
Change in trace metal concentrations from baseline, 12 months, and 24 months
Baseline (within 1 month of surgery), 12 months post-surgery, 24 months post-surgery; and versus healthy controls
Study Arms (2)
Implant Groups
EXPERIMENTALGroup will receive the Smith \& Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant
Healthy Control Group
NO INTERVENTIONControl group that will not be undergoing a total knee arthroplasty
Interventions
Eligibility Criteria
You may qualify if:
- The participants receiving a knee implant must requiring a total knee replacement
You may not qualify if:
- Any degenerative conditions (other than osteoarthritis at the affected knee) impacting joints of the lower extremities
- bilateral knee replacements
- previous joint replacement at the affected knee
- any other past or present conditions that may impact gait
- any active infection and any diagnosed conditions that may affect the local and systemic immune response (e.g., rheumatoid arthritis, HIV infection, lupus, pregnancy, and thrombocytosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- University of Ottawacollaborator
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Lamontagne, PhD
University of Ottawa
- PRINCIPAL INVESTIGATOR
Isabelle Catelas, PhD, PEng
University of Ottawa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2018
First Posted
September 26, 2019
Study Start
April 29, 2019
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR