Clinical trial NCT02230215: Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty
Official title: Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Total Knee Replacement
Visionaire
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Orthopaedic Foundation
name: Smith & Nephew, Inc.
First posted: 2014-09-03
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging to determine whether patient-specific instrumentation for total knee arthroplasty (replacement) has an effect on implant loosening compared to conventional instrumentation. Secondary objectives will include assessment of post-operative implant alignment, patient satisfaction, operative time and surgical instrument use, cost, and environmental impact.

Detailed description: This is a prospective randomized controlled trial which will enroll 50 patients undergoing total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half (25)of these patients will be randomized to have their MRI used to develop a patient-specific instrument to be used during their surgery. The other half (25) will have conventional instrumentation (CI) used for their knee replacement surgery.

All patients will have the same type of knee implant used for their total knee replacement (Genesis II posterior stabilized (Smith \& Nephew).

Patients will not know which group they have been randomized to. For patients randomized into the patient-specific randomization group, If the surgeon is not happy with the patient-specific instrumentation, they have the option to switch to conventional instrumentation at any time during the surgery.

• Length of operation, number of instruments used, amount of OR room waste and number and type of adjustments to the patient specific instrumentation will be tracked.

During the surgery, all patients in the study will have tantalum marker beads placed in the bone surrounding their knee replacement. These beads will be used as markers to measure implant fixation over the next two years. All patients will undergo a special type of x-ray imaging called RSA imaging to quantify implant fixation over time.

RSA examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the Robart's Research Institute after their standard of care visit with orthopaedic surgeon.

Model based RSA software used to measure motion of implant components relative to bone markers.

All patients will complete our standard outcome measures in the form of surveys completed at their follow-up visits after surgery. •

Eligibility criteria: Inclusion Criteria:

* Undergoing primary total knee replacement surgery
* No previous knee hardware (ie.Uni-Knees, or high tibial osteotomy)
* BMI \< 40
* Study patients should live within 100 km of our facility to ensure availability for follow-up

Exclusion Criteria:

* Pregnancy or considering pregnancy
* BMI \> 40
* Unable to undergo MRI screening

Primary outcomes:
measure: Evaluating the Change in Implant Fixation assessed using RSA imaging
timeFrame: 2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years
Secondary outcomes:
measure: Patient Outcomes including Satisfaction
timeFrame: Preoperatively, 1 year, 2 year
Other outcomes:
measure: Component Alignment
timeFrame: 1 year, 2 year
measure: Cost
timeFrame: Intraoperatively
Locations:
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Douglas Naudie, MD
role: PRINCIPAL_INVESTIGATOR
References: