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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Visionaire
Traditional
Sponsored by
Orthopaedic Innovation Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total knee replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Concordia Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Custom Block Instrumentation

Traditional Instrumentation

Arm Description

Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system

Traditional cutting methods for Total Knee Replacement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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).
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.
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).

Full Information

First Posted
December 13, 2017
Last Updated
September 30, 2021
Sponsor
Orthopaedic Innovation Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03416946
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2011 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthopaedic Innovation Centre

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Total knee replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.
Masking
Participant
Masking Description
Randomization will occur after enrolment and subjects will be blinded to assignment group. All subjects will be scheduled for and receive the same MRI experience. It is not possible to blind the surgeon to the surgical technique.
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Custom Block Instrumentation
Arm Type
Active Comparator
Arm Description
Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system
Arm Title
Traditional Instrumentation
Arm Type
Active Comparator
Arm Description
Traditional cutting methods for Total Knee Replacement
Intervention Type
Device
Intervention Name(s)
Visionaire
Intervention Description
Custom cutting block using MRI to create patient specific instrumentations
Intervention Type
Other
Intervention Name(s)
Traditional
Intervention Description
Traditional cutting method
Primary Outcome Measure Information:
Title
Radiographic Alignment
Description
Using 3 foot standing film
Time Frame
8 Weeks
Title
Number of HKA Angle Outliers
Description
The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
EuroQol (EQ) Five Dimension (5D) Survey
Description
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.
Time Frame
Preoperative, 1 and 2 years
Title
Oxford Knee Score
Description
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.
Time Frame
Preoperative, 1 and 2 years
Title
Pain Catastrophizing Scale (PCS) Score
Description
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.
Time Frame
Preoperative, 1 and 2 years
Title
Hip Pain
Description
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).
Time Frame
Preoperative, 1 and 2 years
Title
University of California Los Angeles (UCLA) Activity Score
Description
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.
Time Frame
Preoperative, 1 and 2 years
Title
Patient Satisfaction
Description
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).
Time Frame
Preoperative, 1 and 2 years
Other Pre-specified Outcome Measures:
Title
Other Measure: Time
Description
Surgical and tourniquet time
Time Frame
Intra-operative
Title
Blood Loss
Description
Blood loss during surgery >100ml (n)
Time Frame
Intra-operative
Title
Length of Stay (LOS)
Description
Length of hospital stay
Time Frame
Peri-operative
Title
Other Measures: Adverse Events
Description
Peri-operative complications such as deep venous thrombosis, pulmonary emboli, wound complications and cardiac events. Post-operative complication such as infection, loosening, etc.
Time Frame
Peri-operative, intra-operative and post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient is male or female ages 18 and over. Patient is having primary total knee replacement Patient is willing to sign the informed consent and to come for all study visits. Exclusion Criteria: Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set. 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. 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. Patients scheduled for bilateral knee surgery (simultaneous or staged)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Turgeon, MD MPH FRCSC
Organizational Affiliation
Orthopaedic Innovation Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concordia Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31782643
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.
Results Reference
derived

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

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