A Comparison of the Persona Total Knee Arthroplasty System Using CR or MC Polyethylene

NCT03568123 | Completed

• 1 other identifier: H-16034695
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. 1961). 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. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Therefore such design changes and proposed benefits need to be evaluated in a prospective clinical trail, with focus on patient safety, satisfaction and implant durability. In this project the investigators wish to: Evaluate stability and fixation, intra-operative and postop complications, survivorship and patient reported outcome measures following primary total knee replacement using MC polyethylene bearing compared to CR polyethylene bearing with Persona Total Knee for treatment of knee osteoarthritis. This project is carried out as a 2-arm randomized controlled single-blinded trial, in which the clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing are compared. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the Danish Data Protections Agency is obtained. A total of 60 participants are to be included at Hvidovre University Hospital. Recruitment is expected completed after a period of 1.5 year. The project is expected to be completed 2 years after recruitment of the last participant (2019). Participants are seen on an outpatient basis at 3 months, 1 and 2 years postoperatively. RSA is performed postoperatively and at all outpatient follow-ups. Dynamic RSA is performed at 1 year follow-up. The patients will be followed for survival through The Danish Knee Arthroplasty Registry. This project is financed by Zimmer-Biomet®, Warsaw, Indiana, USA. The primary investigator of this project has independently initiated the project.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Radiostereometric analysis (RSA)

  Radiologically verified stability and fixation is measured as the Maximum total point motion (MTPM) using RSA

  2 years after postoperatively

Secondary Outcomes (17)

• Radiostereometric analysis (RSA)

  3 months postoperatively

• Radiostereometric analysis (RSA)

  1 year postoperatively

• Oxford Knee Score (OKS)

  Change from preoperative to 3 months postoperative OKS

• Oxford Knee Score (OKS)

  Change from preoperative to 1 year postoperative OKS

• Oxford Knee Score (OKS)

  Change from preoperative to 2 years postoperative OKS

Study Arms (2)

MC polyethylene bearing

EXPERIMENTAL

Persona Total Knee System with MC polyethylene bearing

Device: MC polyethylene bearing

CR polyethylene bearing

ACTIVE COMPARATOR

Persona Total Knee System with a CR polyethylene liner.

Device: CR polyethylene bearing

Interventions

MC polyethylene bearing DEVICE

Zimmer Biomet Persona Total Knee System with MC polyethylene bearing. Femoral component: Only cemented femoral components will be used for this study. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Tibial component: Only cemented tibial components will be used for this study. Polyethylene materials: Conventional polyethylene will be used for patients \>65 years old and Vitamine-E infused poly insert for patients ≤ 65 years old.

MC polyethylene bearing

CR polyethylene bearing DEVICE

Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. Femoral component: Only cemented femoral components will be used for this study. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Tibial component: Only cemented tibial components will be used for this study. Polyethylene materials: Conventional polyethylene will be used for patients \>65 years old and Vitamine-E infused poly insert for patients ≤ 65 years old.

CR polyethylene bearing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Physical Status Classification System (ASA) score ≤ 3
• Clinically suitable to receive a Cruciate Retaining (CR) implant (no severe deformity and/or ligament instability)

You may not qualify if:

• Age under 18 years.
• Terminal illness
• Revision knee replacement surgery
• Rheumatoid Arthritis
• 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.

Sponsors & Collaborators

• Anders Troelsen: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (5)

• Charnley J. Arthroplasty of the hip. A new operation. Lancet. 1961 May 27;1(7187):1129-32. doi: 10.1016/s0140-6736(61)92063-3. No abstract available.

  PMID: 15898154 BACKGROUND

• Plate JF, Seyler TM, Stroh DA, Issa K, Akbar M, Mont MA. Risk of dislocation using large- vs. small-diameter femoral heads in total hip arthroplasty. BMC Res Notes. 2012 Oct 5;5:553. doi: 10.1186/1756-0500-5-553.

  PMID: 23039109 BACKGROUND

• Makela KT, Eskelinen A, Pulkkinen P, Paavolainen P, Remes V. Total hip arthroplasty for primary osteoarthritis in patients fifty-five years of age or older. An analysis of the Finnish arthroplasty registry. J Bone Joint Surg Am. 2008 Oct;90(10):2160-70. doi: 10.2106/JBJS.G.00870.

  PMID: 18829914 BACKGROUND

• Geerdink CH, Grimm B, Vencken W, Heyligers IC, Tonino AJ. Cross-linked compared with historical polyethylene in THA: an 8-year clinical study. Clin Orthop Relat Res. 2009 Apr;467(4):979-84. doi: 10.1007/s11999-008-0628-2. Epub 2008 Nov 22.

  PMID: 19030941 BACKGROUND

• Makela KT, Matilainen M, Pulkkinen P, Fenstad AM, Havelin L, Engesaeter L, Furnes O, Pedersen AB, Overgaard S, Karrholm J, Malchau H, Garellick G, Ranstam J, Eskelinen A. Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations. BMJ. 2014 Jan 13;348:f7592. doi: 10.1136/bmj.f7592.

  PMID: 24418635 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Anders Troelsen, Professor

  Department of orthopaedic surgery

  PRINCIPAL INVESTIGATOR

• Kirill Gromov, PhD

  Department of orthopaedic surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are unaware of which prosthesis they receive and the research coordinator handling the collected questionnaires postoperatively is also unaware of which prosthesis the participant has received. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This project is carried out as a 2-arm randomized controlled single-blinded trial, in which the clinical and radiological outcomes after treatment of hip osteoarthritis with insertion of either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing. Allocation of the participants to one of the two treatment groups is done intraoperatively. A computer-generated random allocation sequence will be used. Non-transparent envelopes are used for the randomization process.

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 26, 2018
• Study Start: July 5, 2017
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)