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

Not Applicable

Active, not recruiting

Conditions: Osteoarthritis, Knee

Interventions: Device: Persona total knee system
Device: Nexgen total knee system

Registration Number: NCT03073941

Lead Sponsor: Zimmer Biomet

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

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 332

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Persona CR Total Knee System	Persona total knee system	All patients randomized into this group will have the Intervention: Persona total knee system
NexGen CR Total Knee System	Nexgen total knee system	All patients randomized into this group will have the Intervention: Nexgen total knee system

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Oxford Knee Score - Activity & Participation Questionnaire (APQ)	3 months, 1 year and 2 years postoperatively	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).
Forgotten Joint Score (FJS)	3 months, 1 year and 2 years postoperatively	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.
Patient Satisfaction and Anchoring Questions - Question 1	3 months, 1 year and 2 years postoperatively	Patients were asked to answer the following satisfaction/anchoring question: "How are your knee problems now, compared to prior to your operation?"
Patient Satisfaction and Anchoring Questions - Question 2	3 months, 1 year and 2 years postoperatively	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?"
Patient Satisfaction and Anchoring Questions - Question 3	3 months, 1 year and 2 years postoperatively	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?"
Patient Satisfaction and Anchoring Questions - Question 4	3 months, 1 year and 2 years postoperatively	Patients were asked to answer the following satisfaction/anchoring question: "Would you have your knee operated again?"
EuroQol 5D (EQ-5D) Score	3 months, 1 year and 2 years postoperatively	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.
Radiolucency / Osteolysis	Immediate postoperative and 3 months, 1 year and 2 years postoperatively	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.
Long-term Survivorship	5, 7 and 10 years postoperatively.	Registry data at 5, 7 and 10 years postoperatively.

Trial Locations

Locations (5): Dept. of Orthopaedic Surgery, Næstved Sygehus
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Næstved, Denmark
Dept. of Orthopaedic Surgery, Farsø Sygehus, Ålborg Universitetshospital
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Aalborg, Denmark
Copenhagen University hospital, Gentofte
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Copenhagen, Denmark
Hvidovre hospital
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Copenhagen, Denmark
Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt
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Vejle, Denmark