NCT02430129

Brief Summary

This study is a randomized controlled trial comparing total knee arthroplasty (TKA) to unicompartmental knee arthroplasty (UKA) in patients with no to moderate anteromedial knee osteoarthritis. TKA patients will receive the Zimmer Persona (Warsaw, IN) posterior cruciate retaining total knee arthroplasty, while UKA patients will receive the Biomet Oxford (Warsaw, IN) mobile bearing unicompartmental knee arthroplasty. Outcome measures will include Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Oxford Knee Score (OKS) questionnaires, as well as biomechanics and EMG analysis from the investigating gait lab. The investigators hypothesize that post-operative UKA patients will display higher clinical scores using WOMAC and OKS questionnaires, and superior biomechanical analysis measures. The investigators further hypothesize that the biomechanics data will assist in the understanding of the outcome score differential both pre- and post-operatively in both groups, as well as between-groups. Total follow up period will be two years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

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

First Submitted

Initial submission to the registry

April 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 13, 2025

Status Verified

December 1, 2021

Enrollment Period

5.8 years

First QC Date

April 22, 2015

Last Update Submit

March 11, 2025

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    2 years

  • Oxford Knee Score (OKS)

    2 years

Secondary Outcomes (1)

  • Gait analysis score

    1 year

Study Arms (2)

Total knee arthroplasty/Persona

ACTIVE COMPARATOR

Total knee arthroplasty with Zimmer Persona posterior cruciate retaining prosthesis (Zimmer, Warsaw, IN)

Procedure: Total knee arthroplastyDevice: Persona

Unicompartment knee arthroplasty/Oxford

EXPERIMENTAL

Unicompartmental knee arthroplasty with Biomet Oxford mobile-bearing unicompartmental knee prosthesis (Biomet, Warsaw, IN)

Procedure: Unicompartment knee arthroplastyDevice: Oxford

Interventions

Total knee arthroplastyPROCEDURE

Zimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN)

Total knee arthroplasty/Persona
Unicompartment knee arthroplastyPROCEDURE

Biomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN)

Unicompartment knee arthroplasty/Oxford
PersonaDEVICE

Zimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN)

Total knee arthroplasty/Persona
OxfordDEVICE

Biomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN)

Unicompartment knee arthroplasty/Oxford

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anteromedial compartment osteoarthritis (OA) with intact anterior cruciate ligament (ACL) by clinical testing and alignment on radiographs;
  • normal or mild to moderate patellofemoral joint OA
  • angular deformity \<15 degrees passively correctible to neutral;
  • flexion contracture\<5 degrees;
  • age 40-80 years

You may not qualify if:

  • severe PFJOA;
  • history of previous surgery on the affected knee (excluding simple meniscectomy);
  • inflammatory arthropathy;
  • previous contralateral knee replacement surgery or major ligament reconstruction surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Hip and Knee Clinic

Calgary, Alberta, T2P 3C5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Kelly D Johnston, MD

    University of Calgary Cumming School of Medicine

    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
Chief, Division of Joint Reconstruction - University of Calgary

Study Record Dates

First Submitted

April 22, 2015

First Posted

April 30, 2015

Study Start

February 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 13, 2025

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)