Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, knee
Treatments triathlon total knee system with x3 insert, scorpio nrg total knee system with x3 insert, triathlon pkr system with x3 insert
Sponsor Stryker European Operations BV
Start date June 2012
End date March 2024
Trial size 224 participants
Trial identifier NCT02525562, K-S-044

Summary

Provide outcomes information with regard to surgical and implant performance and patient clinical outcomes of the patients who are eligible for either a Total Knee Arthroplasty (TKA) replacement surgery or Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Patients eligible for Scorpio NRG Total Knee System with X3 insert
scorpio nrg total knee system with x3 insert
Total knee replacement
(Other)
Patients eligible for Triathlon Total Knee System with X3 insert
triathlon total knee system with x3 insert
Total knee replacement
(Other)
Patients eligible for Triathlon PKR System with X3 insert
triathlon pkr system with x3 insert
Partial Knee Resurfacing

Primary Outcomes

Measure
Survivorship of the device
time frame: 10 years follow-up

Secondary Outcomes

Measure
Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)
time frame: pre-operative, 1, 3, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire.
time frame: pre-operative, 1, 3, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with the EuroQuol-5 dimension health questionnaire (EQ-5D) patient questionnaire.
time frame: pre-operative, 1, 3, 5, 7 and 10 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. Patients requiring primary TKA, suitable for the use of the Scorpio NRG with X3 insert or Triathlon Total Knee System with X3 insert, or, patients requiring partial knee resurfacing (unicompartmental knee) suitable for the use of the Triathlon PKR (Partial Knee Resurfacing) System with X3 insert 2. Patients who understand the conditions of the outcomes registry and are willing and able to comply with the standard post-operative evaluations and the prescribed rehabilitation. 3. Patients who signed the Informed Consent Form (approved by Ethics Committee if required) prior to surgery. Exclusion Criteria:

Additional Information

Official title Stryker NTX Registry Scorpio NRG Triathlon Total Knee, Triathlon PKR With X3 Insert International Multicentre Outcomes Register
Principal investigator Romain Seil, MD
Description The objective of this registry is to provide outcomes information with regard to surgical and implant performance and patient clinical outcomes of the patients who are eligible for a either a Total Knee Arthroplasty (TKA) replacement surgery involving the Scorpio NRG or Triathlon Total Knee System or Triathlon PKR Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA), all of which with X3 inlay. The register will follow the standard clinical procedures used by the institutions for patient selection for knee arthroplasty surgery, patient surgery and patient follow-up. Therefore there will be, with regard to this register, no additional assessment, examination, procedure or follow-up visits compared to those usually performed in the institution (routine standard normal procedures).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Stryker European Operations BV.