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Comparison of Three Knee Replacements

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ClinicalTrials.gov Identifier: NCT03339557
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Tero Irmola, Coxa, Hospital for Joint Replacement

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Arthroplasty Total Knee Replacement Device: NexGen Device: Persona Device: PFC Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Official Title: Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Changes in PROMs, Functional improvement [ Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years ]
    Forgotten Joint Score (FJS)

  2. Changes in health-related quality of life (HRQoL) [ Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years ]
    15D

  3. Changes in activity rating scale [ Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years ]
    UCLA activity score

  4. Changes in pain scale measurement [ Time Frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years ]
    VAS pain scale



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339557


Contacts
Contact: Tero Irmola, MD +358331178150 tero.irmola@coxa.fi
Contact: Antti Eskelinen, MD, PhD +358331178153 antti.eskelinen@coxa.fi

Locations
Finland
Coxa, Hospital for Joint Replacement Recruiting
Tampere, Pirkanmaa, Finland, 33101
Contact: Tero Irmola, MD    +358331178150    tero.irmola@coxa.fi   
Contact: Antti Eskelinen, MD, PhD    +358331178153    antti.eskelinen@coxa.fi   
Principal Investigator: Tero Irmola, MD         
Sponsors and Collaborators
Coxa, Hospital for Joint Replacement
Investigators
Principal Investigator: Tero Irmola, MD Coxa, Hospital for Joint Replacement

Publications:

Responsible Party: Tero Irmola, orthopaedic surgeon, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier: NCT03339557     History of Changes
Other Study ID Numbers: R15053
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases