Comparison of Three Knee Replacements

Study Overview
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Brief Summary
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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
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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).

Official Title
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Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants

Conditions
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Osteoarthritis, Knee, Arthroplasty, Total Knee Replacement

Intervention / Treatment
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* Device: NexGen
* Device: Persona
* Device: PFC


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PFC Total Knee Replacement<br>PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital. | Device: NexGen<br>* Comparing two conventional designs and one novel design<br>Device: Persona<br>* Comparing two conventional designs and one novel design<br>|
| Active Comparator: NexGen Total Knee Replacement<br>NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital. | Device: Persona<br>* Comparing two conventional designs and one novel design<br>Device: PFC<br>* Comparing two conventional designs and one novel design<br>|
| Active Comparator: Persona Total Knee Replacement<br>Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital. | Device: NexGen<br>* Comparing two conventional designs and one novel design<br>Device: PFC<br>* Comparing two conventional designs and one novel design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patient reported outcome measures scores (PROMs), Functional improvement | Oxford Knee Score (OKS) | preoperative, postoperative at 2-3 months, at 1 year and at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in PROMs, Functional improvement | Forgotten Joint Score (FJS) | preoperative, postoperative at 2-3 months, at 1 year and at 2 years | 
| Changes in health-related quality of life (HRQoL) | 15D | preoperative, postoperative at 2-3 months, at 1 year and at 2 years | 
| Changes in activity rating scale | UCLA activity score | preoperative, postoperative at 2-3 months, at 1 year and at 2 years | 
| Changes in pain scale measurement | VAS pain scale | preoperative, postoperative at 2-3 months, at 1 year and at 2 years |