NCT03290170

Brief Summary

This is a randomized study comparing the measured resection and gap-balancing surgical techniques for total knee replacement (TKR) using a cemented Journey II TKR implant system. We will be comparing the two surgical methods by evaluating implant migration using radiostereometric analysis (RSA) imaging, evaluating contact kinematics (knee mechanics) through RSA under dynamic conditions and comparing patient knee outcome scores.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

September 19, 2017

Last Update Submit

April 26, 2019

Conditions

Knee OsteoarthritisKnee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Implant migration

    Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging

    2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively

Secondary Outcomes (1)

  • Contact Kinematics Under Dynamic Conditions

    3 and 12 months post-operatively

Other Outcomes (1)

  • Patient-reported outcomes (PROs)

    2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively

Study Arms (2)

Measured resection technique

EXPERIMENTAL

Measured resection surgical technique

Procedure: Measured Resection

Gap Balancing Technique

EXPERIMENTAL

Gap Balancing surgical technique

Procedure: Gap Balancing

Interventions

Measured ResectionPROCEDURE

Bony landmarks are used to set femoral component rotation.

Measured resection technique
Gap BalancingPROCEDURE

Relies on ligament releases prior to bone cuts.

Gap Balancing Technique

Eligibility Criteria

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

You may qualify if:

  • Over the age of 18 years
  • Primary, unilateral total knee arthroplasty

You may not qualify if:

  • History of alcoholism
  • Inability to speak or read English (questionnaires are only provided in English)
  • Pregnant women and women with plans to begin a family
  • Inflammatory arthritis -Bilateral total knee arthroplasty
  • Revision total knee arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Douglas Naudie, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 21, 2017

Study Start

December 20, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

CA(1)