Comparison of Three Knee Replacements

February 1, 2019 updated by: Tero Irmola, Coxa, Hospital for Joint Replacement

Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants

The present randomized controlled trial is designed to compare one novel total knee replacement (TKR) design and two conventional TKR designs in terms of functional outcome. 80 patients will be randomized in each of the three arms (240 altogether).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will compare the short-term functional outcome (at 2 years) of TKR performed with a novel TKR design (Persona , Zimmer, Warsaw, IN, USA) against TKRs performed with two conventional designs (PFC, DePuy, Warsaw, IN, USA and Nexgen, Zimmer, Warsaw, IN, USA).

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33101
        • Coxa, Hospital for Joint Replacement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing total knee replacement surgery for primary osteoarthritis
  • no previous open major surgery in the joint ( e.g. osteotomy)
  • unilateral operative treatment, with no plans for surgical treatment of the contralateral knee in the near future
  • patients living in the local hospital district (Pirkanmaa Hospital District)
  • Kellgren-Lawrence grade 3-4 knee osteoarthritis in plain radiographs

Exclusion Criteria:

  • Unwilling to provide informed consent
  • > 15 degrees varus or valgus, or >15 degree fixed flexion deformity
  • predominantly patellofemoral osteoarthritis
  • Physical, emotional or neurological conditions that would compromise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PFC Total Knee Replacement
PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
Device: NexGen
Comparing two conventional designs and one novel design
Device: Persona
Comparing two conventional designs and one novel design
Active Comparator: NexGen Total Knee Replacement
NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
Device: Persona
Comparing two conventional designs and one novel design
Device: PFC
Comparing two conventional designs and one novel design
Active Comparator: Persona Total Knee Replacement
Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.
Device: NexGen
Comparing two conventional designs and one novel design
Device: PFC
Comparing two conventional designs and one novel design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Oxford Knee Score (OKS)
preoperative, postoperative at 2-3 months, at 1 year and at 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in PROMs, Functional improvement
Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Forgotten Joint Score (FJS)
preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in health-related quality of life (HRQoL)
Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
15D
preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in activity rating scale
Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
UCLA activity score
preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in pain scale measurement
Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
VAS pain scale
preoperative, postoperative at 2-3 months, at 1 year and at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coxa, Hospital for Joint Replacement

Investigators

  • Principal Investigator: Tero Irmola, MD, Coxa, Hospital for Joint Replacement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R15053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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