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Comparison of Three Knee Replacements

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ClinicalTrials.gov Identifier: NCT03339557
Recruitment Status : Active, not recruiting
First Posted : November 13, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Tero Irmola, Coxa, Hospital for Joint Replacement

Tracking Information
First Submitted Date  ICMJE November 7, 2017
First Posted Date  ICMJE November 13, 2017
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE September 1, 2015
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
  • Changes in PROMs, Functional improvement [ Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years ]
    Forgotten Joint Score (FJS)
  • Changes in health-related quality of life (HRQoL) [ Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years ]
    15D
  • Changes in activity rating scale [ Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years ]
    UCLA activity score
  • Changes in pain scale measurement [ Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years ]
    VAS pain scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Three Knee Replacements
Official Title  ICMJE Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will be recruited from Coxa outpatient clinic according to inclusion and exclusion criteria. The participating orthopedic surgeons will recruit patients along their out-patient work. The indications for the surgical treatment in the study will follow the routine clinical guidelines of the hospital. When TKR surgery is decided, the eligible patients will be informed and those willing to participate will be randomized into one of the three implant groups.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Patients will be operated upon using the implant allocated in randomization. Participants are blinded to the implant design used for their operation. Staff at the ward is also blinded. And the physiotherapists conducting the follow-up visits (at 2-3 months, 1 year and 2 years, i.e. the outcome assessors) are also blinded to the allocation.
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Arthroplasty
  • Total Knee Replacement
Intervention  ICMJE
  • Device: NexGen
    Comparing two conventional designs and one novel design
  • Device: Persona
    Comparing two conventional designs and one novel design
  • Device: PFC
    Comparing two conventional designs and one novel design
Study Arms  ICMJE
  • Active Comparator: PFC Total Knee Replacement
    PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
    Interventions:
    • Device: NexGen
    • Device: Persona
  • Active Comparator: NexGen Total Knee Replacement
    NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
    Interventions:
    • Device: Persona
    • Device: PFC
  • Active Comparator: Persona Total Knee Replacement
    Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.
    Interventions:
    • Device: NexGen
    • Device: PFC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 9, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03339557
Other Study ID Numbers  ICMJE R15053
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tero Irmola, Coxa, Hospital for Joint Replacement
Study Sponsor  ICMJE Coxa, Hospital for Joint Replacement
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tero Irmola, MD Coxa, Hospital for Joint Replacement
PRS Account Coxa, Hospital for Joint Replacement
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP