Recruiting

TKA Implants

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04105179

Conditions

Osteoarthritis, Knee

Inflammation Knees

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Zimmer NexGen LPS-Flex

Smith & Nephew Journey II

Study Details

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.

Conditions

Osteoarthritis, Knee

Inflammation Knees

Study ID

NCT04105179

Start date

Apr 29, 2019

Status verified date

Aug, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • The participants receiving a knee implant must requiring a total knee replacement

Exclusion Criteria:

  • 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.

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Implant Groups

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

no intervention: Healthy Control Group

Control group that will not be undergoing a total knee arthroplasty

Interventions

Zimmer NexGen LPS-Flex

Patients will be randomly assigned to 1 of 2 devices

Smith & Nephew Journey II

Patients will be randomly assigned to 1 of 2 devices

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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Wade Gofton, MD FRCSC

6137985555wgofton@toh.ca

Meaghan Dufresne

613-737-8899meadufresne@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Aug 8, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2022-08-08.