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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03073941
• Other study ID #: K.CR.I.EU.15.13
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 31, 2031

Study information

• Verified date: November 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 314
• Est. completion date: December 31, 2031
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Denmark	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	Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system system compared to NexGen total Knee System	Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system system compared to NexGen total Knee System as measured by: Oxford Knee Score	2 years postoperatively
Secondary	Evaluate patient reported Physical activity and participation following primary total knee replacement using Persona Total Knee system compared to NexGen total Knee System	Oxford Knee Score -Activity & Participation Questionnaire (APQ)	3m, 1y, 2 years postoperatively
Secondary	Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system compared to NexGen total Knee System	Forgotten Joint Score (FJS)	3m, 1y, 2 years postoperatively
Secondary	Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system compared to NexGen total Knee System	Anchoring questions	3m, 1y, 2 years postoperatively
Secondary	Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system compared to NexGen total Knee System	EuroQuol 5D(EQ-5D) Score	3m, 1y, 2 years postoperatively
Secondary	Evaluate implant positioning following primary total knee replacement using Persona Total Knee system compared to NexGen total Knee System.	Measure Radiolucency / osteolysis Adverse Events including intraoperative complications and revisions at any post-operative time points.; Survival through registries at 5,7 and 10 years postoperatively.	3m, 1y, 2 year postoperatively
Secondary	Evaluate long-term survivorship following primary total knee replacement using Persona Total Knee system compared to NexGen total Knee System.	Registry data at 5,7 and 10 years postoperatively.	5,7 and 10 years postoperatively.
Secondary	Evaluate intra-operative and postop complications following primary total knee replacement using Persona Total Knee system compared to NexGen total Knee System.	Register Adverse Events including intraoperative complications and revisions at any post-operative time points.; Survival through registries at 5,7 and 10 years postoperatively.	Continuously throughout the study until 10 y