Persona Versus NexGen

Status Completed

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02269254
Study type	Interventional
Source	Leiden University Medical Center
Contact
Status	Completed
Phase	N/A
Start date	September 2014
Completion date	June 2019

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT04976972` - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation	N/A
Recruiting	`NCT05546541` - Epidemiology and Nutrition
Completed	`NCT05071469` - Comparison of Two Different Treatment Methods	N/A
Completed	`NCT05041400` - Distribution of Knee Isokinetic Angle-specific Moments and Ratios	N/A
Not yet recruiting	`NCT04932993` - Writing Down Goals	N/A
Completed	`NCT02944448` - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee	Phase 2
Completed	`NCT02257489` - Phase 1 Study of ACE-083 in Healthy Subjects	Phase 1
Completed	`NCT02256098` - RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA	N/A
Completed	`NCT01979731` - Effects Job Rotation in the Prevention of Work Related Musculoskeletal Disorders	N/A
Active, not recruiting	`NCT01440153` - Additional Exercise Program in Professional Dancers	N/A
Completed	`NCT00968266` - Improving Beliefs About Medication in Patients With Rheumatoid Arthritis	N/A
Completed	`NCT05222126` - Efficacy of Ultrasound-Guided Hydrodissection in Carpal Tunnel Syndrome	N/A
Completed	`NCT05062694` - Physical Therapy Management Of The Patient With Central Sensitization
Recruiting	`NCT05564182` - High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain	N/A
Completed	`NCT04009369` - Impacts of Physiotherapy Services in a Quebec Emergency Department	N/A
Completed	`NCT05561452` - The Efficacy of PRP Injection in the Treatment of Rotator Cuff Syndrome	N/A
Recruiting	`NCT05432609` - Standardization and Reproducibility Regarding Scanning Procedures and Measurements of Weight-bearing Cone Beam CT in the Lower Extremity
Completed	`NCT04959162` - The Effect of Theoretical Knowledge on Resident's Practical Performance in Musculoskeletal Ultrasound	N/A
Completed	`NCT04169646` - Prevention and Intervention of Neck Pain in Swiss Office-Workers	N/A
Recruiting	`NCT05610098` - Gene Expression Profiles in Spinal Tuberculosis.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.