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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Persona total knee system; Device: Nexgen total knee system

Detailed Description

Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee. There is an increasing demand for joint replacement in a younger population. Due to the changing demographics of joint replacement, the population of younger patients are seeking options that not only correct their disease or deformity, but do not limit them in activity. Studies have shown that modern implant designs can potentially improve outcome. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. Within Total knee arthroplasty, design changes are introduced in an attempt to improve knee kinematics, functionality and outcome, but those potential improvements need to be evaluated.

The NexGen Total Knee System is a knee replacement system with well a documented performance and has been the device of choice in many institutions. Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. Such design changes and proposed benefits need to be evaluated in a prospective clinical trial, with focus on patient safety, satisfaction and implant durability.

The aim is to evaluate intra-operative and postop complications, long-term survivorship and patient reported outcome measures following primary total knee replacement using Persona Cruciate Retaining (CR) total Knee system compared to NexGen Cruciate Retaining (CR) total Knee System.

This project is carried out as a 2-arm randomized controlled single-blinded trial. A total of 314 participants are to be included at 6 centers in Denmark. Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. After 2-year follow-up the patients will be followed for survivorship through the Danish Knee Arthroplasty Registry.

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, DK-9000
    • Dept. of Orthopaedic Surgery, Farsø Sygehus, Ålborg Universitetshospital
  • Copenhagen, Denmark, DK-2900
    • Copenhagen University hospital, Gentofte
  • Copenhagen, Denmark
    • Hvidovre Hospital
  • Næstved, Denmark, DK-4700
    • Dept. of Orthopaedic Surgery, Næstved Sygehus
  • Vejle, Denmark, DK-7100,
    • Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Persona CR; Patients who received a Persona CR total knee implant	Device: Persona total knee system; 314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen; Other Names: Zimmer Biomet Persona total knee system
Active Comparator: NexGen CR; Patients who received a NexGen CR total knee implant	Device: Nexgen total knee system; 314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen; Other Names: Zimmer Biomet Nexgen total knee system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Knee Score - Activity & Participation Questionnaire (APQ)	The OKS-APQ is an 8 item questionnaire with each question scored from 0 (worst outcome) to 4 (best outcome). The resulting score is then summed and converted to a score ranging from 0 (worst possible score) to a maximum of 100 (best possible score).	3 months, 1 year and 2 years postoperatively
Forgotten Joint Score (FJS)	The FJS-12 is a patient-reported outcome questionnaire that was developed to specifically assess the patient's level of awareness of the joint during daily activities. The FJS consists of twelve questions covering function and pain associated with the knee. For each question, there is a choice of five answers between never (0), almost never (1), seldom (2), sometimes (3) and mostly (4). All scores are summed up and divided by the number of completed items. This value is then multiplied by 25 and thereafter subtracted from 100. An outcome score of 100 (highest possible score) indicates the lowest level of joint awareness, while a total score of 0 indicates the highest level of joint awareness.	3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 1	Patients were asked to answer the following satisfaction/anchoring question: "How are your knee problems now, compared to prior to your operation?"	3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 2	Patients were asked to answer the following satisfaction/anchoring question: "Taking into account all the activities you have during your daily life, your level of pain and functional impairment, do you consider that your current state is satisfactory?"	3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 3	Patients were asked to answer the following satisfaction/anchoring question: "If you answered No, i.e. not satisfied to the result would you consider your current state as being so unsatisfactory that you think the treatment has failed?"	3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 4	Patients were asked to answer the following satisfaction/anchoring question: "Would you have your knee operated again?"	3 months, 1 year and 2 years postoperatively
EuroQol 5D (EQ-5D) Score	The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-3L, each question can be answered in three ways, indicating no, moderate, or extreme pain. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.59; negative numbers correspond to a self-assessed health state worse than being dead.	3 months, 1 year and 2 years postoperatively
Radiolucency / Osteolysis	All X-rays were sent to an independent radiographer. Postoperative lucency was determined as presence of radiolucent intervals at the cement-bone interface. Femoral lucency and tibial lucency are reported separately.	Immediate postoperative and 3 months, 1 year and 2 years postoperatively
Long-term Survivorship	Registry data at 5, 7 and 10 years postoperatively.	5, 7 and 10 years postoperatively.

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Anders Troelsen, Professor, Hvidovre University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): November 23, 2021
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Total knee replacement; Knee function; Knee arthroplasty; Persona total knee system; NexGen total knee system
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Ulcer Agents; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: K.CR.I.EU.15.13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO