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

N/AActive Not RecruitingNCT03073941

Zimmer Biomet332 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

332

Conditions

Osteoarthritis, Knee

Interventions

Persona total knee systemDEVICE

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

Nexgen total knee systemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

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

Outcomes

Primary Outcomes

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

Time frame: 3 months, 1 year and 2 years postoperatively

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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?"

Data from ClinicalTrials.gov

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