Arthroplasty, Osteoarthritis, Knee, Total Knee Replacement
Conditions
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).
Interventions
DEVICENexGen
Comparing two conventional designs and one novel design
DEVICEPersona
Comparing two conventional designs and one novel design
DEVICEPFC
Comparing two conventional designs and one novel design
Sponsors
Coxa, Hospital for Joint Replacement
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patient reported outcome measures scores (PROMs), Functional improvement | preoperative, postoperative at 2-3 months, at 1 year and at 2 years | Oxford Knee Score (OKS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in PROMs, Functional improvement | 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) | preoperative, postoperative at 2-3 months, at 1 year and at 2 years | 15D |
| Changes in activity rating scale | preoperative, postoperative at 2-3 months, at 1 year and at 2 years | UCLA activity score |
| Changes in pain scale measurement | preoperative, postoperative at 2-3 months, at 1 year and at 2 years | VAS pain scale |
Countries
Finland
Outcome results
None listed