Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)

A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Visionaire; Other: Traditional

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 3S8
      • Concordia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Custom Block Instrumentation; Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system	Device: Visionaire; Custom cutting block using MRI to create patient specific instrumentations
Active Comparator: Traditional Instrumentation; Traditional cutting methods for Total Knee Replacement	Other: Traditional; Traditional cutting method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Alignment	Using 3 foot standing film	8 Weeks
Number of HKA Angle Outliers	The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle.	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol (EQ) Five Dimension (5D) Survey	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the EQ-5D (patient reported). The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, this health state is range from 0 to 1.0. Higher scores indicate improved quality of life within each dimension.	Preoperative, 1 and 2 years
Oxford Knee Score	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Oxford 12 scores (patient reported). The score ranges from 0 to 48 with higher scores indicating improved function and less pain.	Preoperative, 1 and 2 years
Pain Catastrophizing Scale (PCS) Score	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the PCS (patient reported). The total score ranges from 0 to 52 with higher scores indicating greater pain catastrophizing. Sub-scales will not be used in this study.	Preoperative, 1 and 2 years
Hip Pain	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Pain Visual Analog Scale (VAS). The scale is from 0 to 100, 0=no pain and at 100= worst pain. (patient reported).	Preoperative, 1 and 2 years
University of California Los Angeles (UCLA) Activity Score	Evaluate change from preoperative baseline to 1 and 2 year post operative in activity level assessments using the UCLA Activity score (patient reported). The scale ranges from 1-10 with higher values associated with more intense activities.	Preoperative, 1 and 2 years
Patient Satisfaction	Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Satisfaction Visual Analog Scale (VAS). The scale is from 0 to 100, 0=Not Satisfied and at 100=Satisfied. (patient reported).	Preoperative, 1 and 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Measure: Time	Surgical and tourniquet time	Intra-operative
Blood Loss	Blood loss during surgery >100ml (n)	Intra-operative
Length of Stay (LOS)	Length of hospital stay	Peri-operative
Other Measures: Adverse Events	Peri-operative complications such as deep venous thrombosis, pulmonary emboli, wound complications and cardiac events. Post-operative complication such as infection, loosening, etc.	Peri-operative, intra-operative and post-operative

Collaborators and Investigators

• Sponsor: Orthopaedic Innovation Centre
• Investigators: Principal Investigator: Thomas Turgeon, MD MPH FRCSC, Orthopaedic Innovation Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Total knee replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HS13322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes