NCT03416946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 4, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

5.4 years

First QC Date

December 13, 2017

Results QC Date

March 17, 2020

Last Update Submit

September 30, 2021

Conditions

Osteoarthritis, Knee

Keywords

Total knee replacement

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • EuroQol (EQ) Five Dimension (5D) Survey

    Preoperative, 1 and 2 years

  • Oxford Knee Score

    Preoperative, 1 and 2 years

  • Pain Catastrophizing Scale (PCS) Score

    Preoperative, 1 and 2 years

  • Hip Pain

    Preoperative, 1 and 2 years

  • University of California Los Angeles (UCLA) Activity Score

    Preoperative, 1 and 2 years

  • +1 more secondary outcomes

Other Outcomes (4)

  • Other Measure: Time

    Intra-operative

  • Blood Loss

    Intra-operative

  • Length of Stay (LOS)

    Peri-operative

  • +1 more other outcomes

Study Arms (2)

Custom Block Instrumentation

ACTIVE COMPARATOR

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

Device: Visionaire

Traditional Instrumentation

ACTIVE COMPARATOR

Traditional cutting methods for Total Knee Replacement

Other: Traditional

Interventions

VisionaireDEVICE

Custom cutting block using MRI to create patient specific instrumentations

Custom Block Instrumentation
TraditionalOTHER

Traditional cutting method

Traditional Instrumentation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 31782643DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Trevor Gascoyne
Organization
Orthopaedic Innovation Centre
tgascoyne@orthoinno.com
204-926-1235

Study Officials

  • Thomas Turgeon, MD MPH FRCSC

    Orthopaedic Innovation Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

December 13, 2017

First Posted

January 31, 2018

Study Start

December 1, 2011

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

October 4, 2021

Results First Posted

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)