A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen
1 other identifier
interventional
332
1 country
5
Brief Summary
A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 17, 2017
CompletedFirst Posted
Study publicly available on registry
March 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2021
CompletedResults Posted
Study results publicly available
January 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
ExpectedMay 12, 2026
April 1, 2026
5 years
January 17, 2017
July 26, 2024
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxford Knee Score
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
3 months, 1 year and 2 years postoperatively
Secondary Outcomes (9)
Oxford Knee Score - Activity & Participation Questionnaire (APQ)
3 months, 1 year and 2 years postoperatively
Forgotten Joint Score (FJS)
3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 1
3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 2
3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 3
3 months, 1 year and 2 years postoperatively
- +4 more secondary outcomes
Study Arms (2)
Persona CR
ACTIVE COMPARATORPatients who received a Persona CR total knee implant
NexGen CR
ACTIVE COMPARATORPatients who received a NexGen CR total knee implant
Interventions
314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen
314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (5)
Dept. of Orthopaedic Surgery, Farsø Sygehus, Ålborg Universitetshospital
Aalborg, DK-9000, Denmark
Copenhagen University hospital, Gentofte
Copenhagen, DK-2900, Denmark
Hvidovre hospital
Copenhagen, Denmark
Dept. of Orthopaedic Surgery, Næstved Sygehus
Næstved, DK-4700, Denmark
Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt
Vejle, DK-7100,, Denmark
Related Publications (1)
Mortensen KRL, Ingelsrud LH, Odgaard A, Kappel A, Varnum C, Schroder H, Gromov K, Troelsen A. Patient-reported outcomes and complications of a new-generation total knee system: a randomized controlled trial. Acta Orthop. 2025 Feb 25;96:195-202. doi: 10.2340/17453674.2025.43004.
PMID: 39998994DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chiara Griffoni, Clinical Project Senior Lead
- Organization
- Zimmer Biomet
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Troelsen, Professor
Hvidovre University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2017
First Posted
March 8, 2017
Study Start
December 1, 2016
Primary Completion
November 23, 2021
Study Completion (Estimated)
December 31, 2031
Last Updated
May 12, 2026
Results First Posted
January 17, 2025
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share