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Clinical Trials in Denmark / NCT03073941
Active, not recruiting Not applicable

A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen

NCT03073941 · tracked via the Priya Life Science Denmark tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2016-12
Last updated
2026-05-12

Condition(s) studied

Osteoarthritis, Knee

Investigational drug(s) / intervention(s)

Persona total knee systemNexgen total knee system

Persona total knee system: 314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen

Nexgen total knee system: 314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen

Study summary

A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement * \>18 years of age * Participants must be able to speak and understand Danish * Participants must be able to give informed consent and be cognitively intact * Participants must be able to complete all post-operative controls * Participants must not have severe comorbidities, American Society of Anesthesiologists (ASA) score ≤ 3 * Clinically suitable to receive a CR implant (no severe deformity and/or ligament instability) Exclusion Criteria: * Terminal illness * Revision knee replacement surgery * Rheumatoid Arthritis (RA) * Traumatic etiology * Prior surgery on the affected knee that includes osteosynthesis, Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL) and/or collateral ligament surgery. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. * Altered pain perception and / or neurologic affection due to diabetes or other disorders. * Patients will be excluded intraoperative if CR implant is not suitable.

Primary outcome measure(s)

  • Oxford Knee Score — 3 months, 1 year and 2 years postoperatively
    The OKS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TKA. The OKS consists of twelve questions covering function and pain associated with the knee. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27

Trial sites (5)

FacilityCityRegionStatus
Dept. of Orthopaedic Surgery, Farsø Sygehus, Ålborg Universitetshospital Aalborg Denmark
Copenhagen University hospital, Gentofte Copenhagen Denmark
Hvidovre hospital Copenhagen Denmark
Dept. of Orthopaedic Surgery, Næstved Sygehus Næstved Denmark
Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt Vejle Denmark

More Zimmer Biomet trials in Denmark

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A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty Active, not recruiting
Comprehensive Segmental Revision System Active, not recruiting
Avenir Complete Post-Market Clinical Follow-Up Study Active, not recruiting
MDR - Comprehensive Primary Revision Stems PMCF Enrolling by invitation

Other trials for the same condition

Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis Active, not recruiting
Study of Intra-articular Allocetra in Knee Osteoarthritis Active, not recruiting
AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain Recruiting
Medial Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty Active, not recruiting
Development of Computational Models to Predict the Short-, Medium- and Long-term Cartilage Degeneration and Pain for Patients With Early-stage Osteoarthritis or Anterior Cruciate Ligament Injury Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03073941 on ClinicalTrials.gov ↗ ← All trials in Denmark