Comparison of Three Knee Replacements

Coxa, Hospital for Joint Replacement240 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

240

Conditions

Osteoarthritis, Knee Arthroplasty Total Knee Replacement

Interventions

NexGenDEVICE

Comparing two conventional designs and one novel design

PersonaDEVICE

Comparing two conventional designs and one novel design

PFCDEVICE

Comparing two conventional designs and one novel design

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.)

Locations (1)

Coxa, Hospital for Joint Replacement

Tampere, Pirkanmaa, Finland