Clinical trial NCT03416946: Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)
Official title: A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Total knee replacement
Lead sponsor: Orthopaedic Innovation Centre
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.
Primary purpose: TREATMENT

Brief summary: To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation.

Detailed description: This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.

Eligibility criteria: Inclusion Criteria:

1. Patient is male or female ages 18 and over.
2. Patient is having primary total knee replacement
3. Patient is willing to sign the informed consent and to come for all study visits.

Exclusion Criteria:

1. Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.
2. Necessity for the use of constrained implants. These types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate.
3. Patients undergoing knee replacement revision surgery. Theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons.
4. Patients scheduled for bilateral knee surgery (simultaneous or staged)

Primary outcomes:
measure: Radiographic Alignment
timeFrame: 8 Weeks
measure: Number of HKA Angle Outliers
timeFrame: 8 Weeks
Secondary outcomes:
measure: EuroQol (EQ) Five Dimension (5D) Survey
timeFrame: Preoperative, 1 and 2 years
measure: Oxford Knee Score
timeFrame: Preoperative, 1 and 2 years
measure: Pain Catastrophizing Scale (PCS) Score
timeFrame: Preoperative, 1 and 2 years
measure: Hip Pain
timeFrame: Preoperative, 1 and 2 years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: Preoperative, 1 and 2 years
measure: Patient Satisfaction
timeFrame: Preoperative, 1 and 2 years
Other outcomes:
measure: Other Measure: Time
timeFrame: Intra-operative
measure: Blood Loss
timeFrame: Intra-operative
measure: Length of Stay (LOS)
timeFrame: Peri-operative
measure: Other Measures: Adverse Events
timeFrame: Peri-operative, intra-operative and post-operative
Locations:
city: Winnipeg
country: Canada
facility: Concordia Hospital
state: Manitoba
Study officials:
affiliation: Orthopaedic Innovation Centre
name: Thomas Turgeon, MD MPH FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turgeon TR, Cameron B, Burnell CD, Hedden DR, Bohm ER. A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation. Can J Surg. 2019 Dec 1;62(6):460-467. doi: 10.1503/cjs.018318.