Stryker NTX Registry Scorpio NRG (Re-"Energize"), Triathlon Total Knee, Triathlon Partial Knee Resurfacing (PKR) With X3 Polyethylene Insert

NCT02525562 | Terminated Results FDA Device

• 1 other identifier: K-S-044
• Study Type: interventional
• Target: 237
• Locations: 3 countries
• Sites: 3

Brief 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)

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Survivorship of the Device

  Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).

  Preoperative to 1 year, 1 year, 3 years, and 5 years. Survivorship is unavailable at 10 years due to study termination.

Secondary Outcomes (3)

• Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)

  Pre-operative, 1, 3, and 5 years. The KSS for 7 and 10 year timepoints are unavailable due to study termination.

• Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.

  Pre-operative, 1, 3, and 5 years. The KOOS for 7 and 10 year timepoints are unavailable due to study termination.

• Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.

  Pre-operative, 1, 3, and 5 years. The EQ-5D for 7 and 10 year timepoints is unavailable due to study termination.

Study Arms (3)

Scorpio NRG Total Knee System

OTHER

Patients eligible for Scorpio NRG Total Knee System with X3 insert

Device: Scorpio NRG Total Knee System with X3 insert; Procedure: Total Knee Replacement

Triathlon Total Knee System

OTHER

Patients eligible for Triathlon Total Knee System with X3 insert

Device: Triathlon Total Knee System with X3 insert; Procedure: Total Knee Replacement

Triathlon Partial Knee Resurfacing

OTHER

Patients eligible for Triathlon PKR System with X3 insert

Device: Triathlon PKR System with X3 insert; Procedure: Partial Knee Resurfacing

Interventions

Triathlon Total Knee System with X3 insert DEVICE

Total knee replacement

Triathlon Total Knee System

Scorpio NRG Total Knee System with X3 insert DEVICE

Total knee replacement

Scorpio NRG Total Knee System

Triathlon PKR System with X3 insert DEVICE

Partial Knee Resurfacing

Triathlon Partial Knee Resurfacing

Total Knee Replacement PROCEDURE

Total Knee Replacement

Scorpio NRG Total Knee System; Triathlon Total Knee System

Partial Knee Resurfacing PROCEDURE

Partial Knee Resurfacing

Triathlon Partial Knee Resurfacing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Patients who signed the Informed Consent Form (approved by Ethics Committee if required) prior to surgery.

You may not qualify if:

• None

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (3)

Kliniken Dr. Erler gGmbH

Nuremberg, Bavaria, 90429, Germany

Location

Centre Hospitalier de Luxembourg

Luxembourg, L-1210, Luxembourg

Location

Worcestersire Acute Hospital NHS Trust, Alexandra Hospital

Redditch, Worcestersire, B98 7UB, United Kingdom

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

The study was terminated at the 5-year timepoint, therefore the primary outcome measure of survivorship of the device at 10-years was not analyzed.

Results Point of Contact

• Title: Stryker JR Clinical Research
• Organization: Stryker Orthopaedics

StrykerJRClinical@stryker.com

201-831-5000

Study Officials

• Romain Seil, MD

  Centre Hospitalier du Luxembourg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: August 17, 2015
• Study Start: June 28, 2012
• Primary Completion: May 28, 2020
• Study Completion: May 28, 2020
• Last Updated: February 22, 2024
• Results First Posted: March 14, 2023

Record last verified: 2024-02

Locations

LU (1); GB (1); DE (1)