Osteoarthritis, KneeNCT04105179
How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response
A study testing Zimmer NexGen LPS-Flex and Smith & Nephew Journey II in people with Osteoarthritis, Knee and Inflammation Knees, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Inflammation Knees
- What is being tested?
- Zimmer NexGen LPS-Flex and Smith & Nephew Journey II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 29 Apr 2019to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participants receiving a knee implant must requiring a total knee replacement
Who cannot join
- 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)
- BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI > 35 kg/m2 and a WC > 102 cm in men or > 88 cm in women will be excluded from the study.
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- Healthy Controls Inclusion
- controls must not suffer from lower extremity injuries or joint conditions that might alter gait dynamics Exclusion
- BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI > 35 kg/m2 and a WC > 102 cm in men or > 88 cm in women will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
About this study
Official title: Do TKA Implant Designs Affect Muscle Mass Change and Muscle Activity During Activities of Daily Living as Well as the Patient Immunological Response
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.
Read the detailed description
Patients will undergo biomechanics testing while they complete sit-to-stand, stand-to-sit, lateral step down, level walking, and single leg balance tasks up to 1 month before surgery, and 6 and 12 months after surgery. They will also undergo MRI imaging up to 1 month before surgery and 12 months after surgery to assess muscle quality. A secondary outcome will also be to analyze the immunological response in the patients who received femoral components made of oxidized zirconium versus contemporary components made of cobalt chrome. Fifteen healthy controls will also participate in the study and will undergo the biomechanical, MRI and blood draws at a single visit.
- Conditions
- Osteoarthritis, Knee, Inflammation Knees
- Being tested
- Zimmer NexGen LPS-Flex, Smith & Nephew Journey II
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer NexGen LPS-FlexDevice
Patients will be randomly assigned to 1 of 2 devices
Smith & Nephew Journey IIDevice
Patients will be randomly assigned to 1 of 2 devices
| Study group | Role | What they receive |
|---|---|---|
| Implant Groups | Experimental | Group will receive the Smith \& Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant Receives: Device: Zimmer NexGen LPS-Flex; Device: Smith & Nephew Journey II |
| Healthy Control Group | No intervention | Control group that will not be undergoing a total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Peripheral blood will be collected prior to surgery and at 12 months post-surgery; for symptomatic patients, a third blood draw will occur at 24 months post-surgery. Concentrations of cobalt, chromium, and Nickle will be measured by inductively coupled plasma-mass spectrometry.
Measured: Baseline (within 1 month of surgery), 12 months post-surgery, 24 months post-surgery; and versus healthy controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start29 Apr 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Sponsor
- Investigators
- Mario Lamontagne, PhD, Principal investigator, University of OttawaIsabelle Catelas, PhD, PEng, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105179
- Sponsor's protocol ID
- 20180532
- Status last verified
- Aug 2022
- First submitted
- 13 Sep 2018
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do TKA Implant Designs Affect Muscle Mass Change and Muscle Activity During Activities of Daily Living as Well as the Patient Immunological Response
- ClinicalTrials.gov ID
- NCT04105179
- Acronym / sponsor ID
- 20180532
- Conditions
- Osteoarthritis, Knee, Inflammation Knees
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will undergo biomechanics testing while they complete sit-to-stand, stand-to-sit, lateral step down, level walking, and single leg balance tasks up to 1 month before surgery, and 6 and 12 months after surgery. They will also undergo MRI imaging up to 1 month before surgery and 12 months after surgery to assess muscle quality. A secondary outcome will also be to analyze the immunological response in the patients who received femoral components made of oxidized zirconium versus contemporary components made of cobalt chrome. Fifteen healthy controls will also participate in the study and will undergo the biomechanical, MRI and blood draws at a single visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant Groups | Experimental | Device: Zimmer NexGen LPS-Flex, Device: Smith & Nephew Journey IIGroup will receive the Smith \& Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant |
| Healthy Control Group | No intervention | –Control group that will not be undergoing a total knee arthroplasty |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants receiving a knee implant must requiring a total knee replacement
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zimmer NexGen LPS-FlexPatients will be randomly assigned to 1 of 2 devices | Device | Implant Groups |
| Smith & Nephew Journey IIPatients will be randomly assigned to 1 of 2 devices | Device | Implant Groups |
Primary outcome
Change from baseline knee extension moment at 6 and 12 months during gait
Time frame: Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
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.
Change from baseline muscle quality assessed via MRI at 12 months
Time frame: Baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls
Proton density fat fraction of the quadriceps and hamstrings muscles will be measured via MRI
Change from baseline quadriceps muscle activation at 6 and 12 months during gait
Time frame: Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
Peak muscle activation of the quadriceps muscle will be measured with electromyography while the participant walks at their normal walking speed
1 secondary outcome
Change in trace metal concentrations from baseline, 12 months, and 24 months
Time frame: Baseline (within 1 month of surgery), 12 months post-surgery, 24 months post-surgery; and versus healthy controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Lamontagne, PhD principal investigator
University of Ottawa
Isabelle Catelas, PhD, PEng principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer NexGen LPS-Flex and Smith & Nephew Journey II in people with Osteoarthritis, Knee and Inflammation Knees, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wade Gofton, MD FRCSC (6137985555 ext. 18779, wgofton@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline knee extension moment at 6 and 12 months during gait (time frame: Baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.