Clinical trial NCT05226689: Porous Baseplate in Total Knee Replacement
Official title: A Prospective, Multicenter, RSA Study of the Porous Tibia Baseplate W/Jrny Lock
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Canadian Radiostereometric Analysis Network
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-centre single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Advance Porous fixed bearing tibial baseplate and compatible femoral, patellar, and bearing components.

Detailed description: All patients will undergo post-operative model-based RSA to identify migration of the tibial baseplate with respect to the bone as well as migration of the patellar and femoral components with respect to the bone during the first 2 post-operative years. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.

Eligibility criteria: Inclusion Criteria:

* Symptomatic osteoarthritis of the knee indicating primary unilateral total knee arthroplasty
* Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
* Aged 21 years or older
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Active or prior infection
* Medical condition precluding major surgery
* Known medical condition limiting patient life expectancy to \< 2 years
* Expected to receive contralateral TKA within 1 year
* Inflammatory arthropathy
* Prior patellectomy
* PCL deficiency
* Major (\>25 degree) coronal plane deformity
* Bilateral coronal plane deformity requiring simultaneous bilateral TKA
* Bone defects requiring augments, cones and/or stemmed implants
* Body Mass Index greater than 40

Primary outcomes:
measure: Change between 6 months and 1-year post-operative - tibial baseplate stability
timeFrame: 6 Months and 1 Year
Secondary outcomes:
measure: Change between 1- and 2-years post-operative - tibial baseplate stability
timeFrame: 1 Year and 2 Years
measure: Total MTPM migration of the baseplate at 1 year
timeFrame: 1 Year
measure: Establish the post-operative migration pattern of the patellar and femoral components
timeFrame: 6 Weeks and 6 Months
measure: What is the magnitude of baseplate displacement that results from patient weight-bearing (single leg stance) versus non-weight-bearing at 1-year post-operation?
timeFrame: 1 Year
measure: European Quality of Life (EQ-5D-5L)
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Patient-reported Outcome: Oxford Knee Score
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Forgotten Joint Score (FJS)
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: University of California at Los Angeles (UCLA) Activity Level scale
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Pain VAS
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Satisfaction VAS
timeFrame: Preoperative, 6 Months, 1 Year and 2 Years
measure: Patient complications
timeFrame: 6 Weeks, 6 Months, 1 Year and 2 Years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Concordia Hospital
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Douglas Naudie, MD
role: PRINCIPAL_INVESTIGATOR
References: