NCT03895489

Brief Summary

The purpose of the study is to determine if knee replacement performed using Journey II implant is different from two other standard-of-care knee replacements using Stryker and Zimmer in terms of knee movements and forces, walking patterns, pain, and function after surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress81%
Sep 2019Dec 2027

First Submitted

Initial submission to the registry

January 29, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2025

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

5.6 years

First QC Date

January 29, 2019

Last Update Submit

July 3, 2025

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (12)

  • knee flexion-extension range of motion (ROM) during level treadmill walking

    Angle of knee measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Degree

    1 month preoperative

  • knee flexion-extension range of motion (ROM) during level treadmill walking

    Angle of knee measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Degree

    1 year post-operative

  • knee abduction-adduction range of motion (ROM) during level treadmill walking

    Angle of knee measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Degree

    1 month preoperative

  • knee abduction-adduction range of motion (ROM) during level treadmill walking

    Angle of knee measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Degree

    1 year post-operative

  • Max velocity of knee flexion-extension during level treadmill walking

    Knee velocity measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: degree/s

    1 month preoperative

  • Max velocity of knee flexion-extension during level treadmill walking

    Knee velocity measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: degree/s

    1 year post-operative

  • Max velocity of knee abduction-adduction during level treadmill walking

    Knee velocity measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: degree/s

    1 month preoperative

  • Max velocity of knee abduction-adduction during level treadmill walking

    Knee velocity measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: degree/s

    1 year post-operative

  • Max moment of knee flexion-extension during level treadmill walking

    Knee moment measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Newton meter

    1 month preoperative

  • Max moment of knee flexion-extension during level treadmill walking

    Knee moment measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Newton meter

    1 year post-operative

  • Max moment of knee abduction-adduction during level treadmill walking

    Knee moment measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Newton meter

    1 month preoperative

  • Max moment of knee abduction-adduction during level treadmill walking

    Knee moment measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Newton meter

    1 year post-operative

Secondary Outcomes (21)

  • Walking velocity during level treadmill walking

    1 month preoperative

  • Walking velocity during level treadmill walking

    1 year post-operative

  • Cadence during level treadmill walking

    1 month preoperative

  • Cadence during level treadmill walking

    1 year post-operative

  • Stride length during level treadmill walking

    1 month preoperative

  • +16 more secondary outcomes

Study Arms (3)

Journey II

EXPERIMENTAL

Smith and Nephew Richards (SNR) Journey II Knee prosthesis

Device: Journey II

Stryker

ACTIVE COMPARATOR

Stryker Triathlon Total Knee prosthesis

Device: Stryker

Zimmer

ACTIVE COMPARATOR

Zimmer Persona® The Personalized Knee prosthesis

Device: Zimmer

Interventions

Journey IIDEVICE

Smith and Nephew Richards (SNR) Journey II Knee prosthesis

Journey II
StrykerDEVICE

Stryker Triathlon Total Knee prosthesis

Stryker
ZimmerDEVICE

Zimmer Persona® The Personalized Knee prosthesis

Zimmer

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant has signed an approved informed consent form.
  • Participant is a male or non-pregnant female and aged 50 to 75 years at the time of study device implantation.
  • Participant has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
  • Participant is a candidate for a primary posterior-stabilized total knee replacement.
  • Participant is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if:

  • Participant has a Body Mass Index (BMI) ≥ 40 kg/m2.
  • Participant has a varus or valgus deformity greater than 15º or flexion contracture greater than 20º or knee flexion range of motion \< 90º in either lower extremity.
  • Participant has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
  • Participant has received any orthopaedic surgical intervention to the lower extremities within the past 6 months or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKA, within the next year.
  • Participant requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement within the past 6 months.
  • Participant has other medical conditions which limit the ability to evaluate the safety and efficacy of the device.
  • Participant requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
  • Participant has a known sensitivity to device materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edmonton Bone and Joint Centre

Edmonton, Alberta, T5E 5R8, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Ailar Ramadi, PhD

CONTACT

780-492-6713Ailar.Ramadi@albertahealthservices.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

March 29, 2019

Study Start

September 9, 2019

Primary Completion

April 3, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

July 9, 2025

Record last verified: 2025-07

Locations

CA(1)