The objective of this study is to accurately assess and compare migration, kinematics, gait analysis, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Migration, measured by means of RSA.
Secondary outcome
* 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 and gait analysis.
* Patient Reported Outcome Measures by means of questionaires.
Background 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.
Study objective
The objective of this study is to accurately assess and compare migration,
kinematics, gait analysis, 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, gait
analysis, prosthesis placement and patient reported outcome measures.
Study design
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
* 20 Patients with NexGen LPS prosthesis and 20 patients with Persona PS
prosthesis for Gait
* 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS
prosthesis for Fluo
Intervention
Total Knee Replacement Surgery
Study burden and risks
Potential risks are risks associated with normal total knee
replacements such as infection, migration, bone loss, pain, loosening
of components, tromboembolic complications and risks involving
anaesthesia. The NexGen LPS knee has an excellent track record, and the
Persona PS knee is considered an improved version of this implant.
While the patients participating in this study may not directly derive any
immediate benefits, the results of the study should improve the understanding
of the fixation and functioning of the prosthesis. This information will be
extremely useful in optimising knee implant designs based on better
fixation and improved long-term results.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Age: 21-90 years, Indications: Patient is diagnosed with osteoarthritis or
rheumatoid arthritis and requiring primary knee arthroplasty, General: 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). , Consent: Patient is capable of giving
informed consent and expressing a willingness to comply with this study
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
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02269254 |
| CCMO | NL47243.058.13 |