An interventional study of NexGen and Persona in Osteoarthritis, Knee, Arthroplasty and Total Knee Replacement, sponsored by Coxa, Hospital for Joint Replacement. Status unknown at 1 site in Finland. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by Coxa, Hospital for Joint Replacement · Not applicable, Interventional, and Treatment
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).
Exclusion Criteria:
PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
Device: NexGen · Device: Persona
NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
Device: Persona · Device: PFC
Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.
Device: NexGen · Device: PFC
Comparing two conventional designs and one novel design
Comparing two conventional designs and one novel design
Comparing two conventional designs and one novel design
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Oxford Knee Score (OKS)
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in PROMs, Functional improvement
Forgotten Joint Score (FJS)
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in health-related quality of life (HRQoL)
15D
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in activity rating scale
UCLA activity score
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in pain scale measurement
VAS pain scale
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Plan to share: No
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Coxa, Hospital for Joint Replacement