Comparison of Three Knee Replacements

Not Applicable

• Conditions: Total Knee Replacement; Osteoarthritis, Knee; Arthroplasty
• Interventions: Device: Persona; Device: NexGen; Device: PFC

• Registration Number: NCT03339557
• Lead Sponsor: Coxa, Hospital for Joint Replacement

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).

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-13
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NexGen Total Knee Replacement	Persona	NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
PFC Total Knee Replacement	NexGen	PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
PFC Total Knee Replacement	Persona	PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
Persona Total Knee Replacement	NexGen	Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.
NexGen Total Knee Replacement	PFC	NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
Persona Total Knee Replacement	PFC	Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Coxa, Hospital for Joint Replacement; 🇫🇮 Tampere, Pirkanmaa, Finland