Clinical trial NCT03073941: A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen
Official title: A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen Total Knee System in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee arthroplasty
Knee function
Total knee replacement
Persona total knee system
NexGen total knee system
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Oxford Knee Score
timeFrame: 3 months, 1 year and 2 years postoperatively
Secondary outcomes:
measure: Oxford Knee Score - Activity & Participation Questionnaire (APQ)
timeFrame: 3 months, 1 year and 2 years postoperatively
measure: Forgotten Joint Score (FJS)
timeFrame: 3 months, 1 year and 2 years postoperatively
measure: Patient Satisfaction and Anchoring Questions - Question 1
timeFrame: 3 months, 1 year and 2 years postoperatively
measure: Patient Satisfaction and Anchoring Questions - Question 2
timeFrame: 3 months, 1 year and 2 years postoperatively
measure: Patient Satisfaction and Anchoring Questions - Question 3
timeFrame: 3 months, 1 year and 2 years postoperatively
measure: Patient Satisfaction and Anchoring Questions - Question 4
timeFrame: 3 months, 1 year and 2 years postoperatively
measure: EuroQol 5D (EQ-5D) Score
timeFrame: 3 months, 1 year and 2 years postoperatively
measure: Radiolucency / Osteolysis
timeFrame: Immediate postoperative and 3 months, 1 year and 2 years postoperatively
measure: Long-term Survivorship
timeFrame: 5, 7 and 10 years postoperatively.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dept. of Orthopaedic Surgery, Farsø Sygehus, Ålborg Universitetshospital
city: Copenhagen
country: Denmark
facility: Copenhagen University hospital, Gentofte
city: Copenhagen
country: Denmark
facility: Hvidovre hospital
city: Næstved
country: Denmark
facility: Dept. of Orthopaedic Surgery, Næstved Sygehus
city: Vejle
country: Denmark
facility: Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt
Study officials:
affiliation: Hvidovre University Hospital
name: Anders Troelsen, Professor
role: PRINCIPAL_INVESTIGATOR
References: