Status:
UNKNOWN
Comparison of Three Knee Replacements
Lead Sponsor:
Coxa, Hospital for Joint Replacement
Conditions:
Osteoarthritis, Knee
Arthroplasty
Eligibility:
All Genders
50-70 years
Phase:
NA
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 random...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03339557
Start Date
September 1 2015
End Date
May 31 2021
Last Update
February 4 2019
Active Locations (1)
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1
Coxa, Hospital for Joint Replacement
Tampere, Pirkanmaa, Finland, 33101