Persona Versus NexGen

Musculoskeletal Diseases Clinical Trial

Official title:

Migration and Kinematics of the New Persona PS Versus the Proven NexGen LPS Knee - a Randomized Controlled Trial Using Radiostereometric Analysis and Fluoroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269254
• Other study ID #: P13.277
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: June 2019

Study information

• Verified date: February 2020
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used successfully in about 20.000 patients, but results from independent clinical studies have not been reported yet.

The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures.

This study is designed as a single-blind randomized trial between the Persona PS total knee prosthesis and the well-established NexGen total knee prosthesis.

Different sample sizes are used for the different parts of this study:

• 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA

• 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo

The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical Center. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be accomplished within a 2 year period.

Main study parameters/endpoints are:

• Migration, measured by means of RSA.

• Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts.

• In vivo kinematics by means of fluoroscopy.

• Patient Reported Outcome Measures by means of questionaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty

• Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Stratification is performed per diagnosis group (OA/RA).

Exclusion Criteria:

• The patient is unable or unwilling to sign the Informed Consent specific to this study

• Insufficient Dutch or English language skills

• Patients indicated for revision arthroplasty

• Patient is (or might be) pregnant

• When there are less than five tibia-bone markers and less than five femur-bone markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria). In case only one of the bones has insufficient markers, the patient will be followed for the other bone.

Related Conditions & MeSH terms

• Collagen Diseases
• Joint Diseases
• Musculoskeletal Diseases
• Osteoarthritis
• Osteoarthritis Arthritis
• Rheumatic Diseases

Intervention

Device:
• Persona PS Knee Prosthesis by Zimmer
Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer
• NexGen PS Knee Prosthesis by Zimmer
Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Zimmer Biomet

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration, measured by means of RSA.	Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).	2 Years
Secondary	Knee Prosthesis motion by means of Fluoroscopy.	Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis.	1 Year
Secondary	EQ-5D	General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire	2 Years
Secondary	KOOS	Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire	2 Years
Secondary	VAS pain	Pain score after activity and during rest; (Likert scale 0-10)	2 Years