Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Coxa, Hospital for Joint Replacement
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Changes in patient reported outcome measures scores (PROMs), Functional improvement
- Last Updated
- 7 years ago
Overview
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).
Investigators
Tero Irmola
orthopaedic surgeon
Coxa, Hospital for Joint Replacement
Eligibility 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.)
Outcomes
Primary Outcomes
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 Outcomes
- Changes in activity rating scale(preoperative, postoperative at 2-3 months, at 1 year and at 2 years)
- Changes in pain scale measurement(preoperative, postoperative at 2-3 months, at 1 year and at 2 years)
- Changes in PROMs, Functional improvement(preoperative, postoperative at 2-3 months, at 1 year and at 2 years)
- Changes in health-related quality of life (HRQoL)(preoperative, postoperative at 2-3 months, at 1 year and at 2 years)