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

Stryker NTX Registry Scorpio NRG Triathlon Total Knee, Triathlon PKR With X3 Insert International Multicentre Outcomes Register

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)

Study Overview

• Status: Terminated
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: Scorpio NRG Total Knee System with X3 insert; Procedure: Total Knee Replacement; Device: Triathlon Total Knee System with X3 insert; Device: Triathlon PKR System with X3 insert; Procedure: Partial Knee Resurfacing

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 237
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Nürnberg, Bayern, Germany, 90429
      • Kliniken Dr. Erler gGmbH
• Luxembourg
  • Luxembourg, Luxembourg, L-1210
    • Centre Hospitalier de Luxembourg
• United Kingdom
  • Worcestersire
    • Redditch, Worcestersire, United Kingdom, B98 7UB
      • Worcestersire Acute Hospital NHS Trust, Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Scorpio NRG Total Knee System; Patients eligible for Scorpio NRG Total Knee System with X3 insert	Device: Scorpio NRG Total Knee System with X3 insert; Total knee replacement; Procedure: Total Knee Replacement; Total Knee Replacement
Other: Triathlon Total Knee System; Patients eligible for Triathlon Total Knee System with X3 insert	Procedure: Total Knee Replacement; Total Knee Replacement; Device: Triathlon Total Knee System with X3 insert; Total knee replacement
Other: Triathlon Partial Knee Resurfacing; Patients eligible for Triathlon PKR System with X3 insert	Device: Triathlon PKR System with X3 insert; Partial Knee Resurfacing; Procedure: Partial Knee Resurfacing; Partial Knee Resurfacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)	The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability (Pain/Motion KSS subscale is 0 to 100, with 100 representing a better outcome), and one for functional parameters (Function KSS subscale is 0 to 100, with 100 representing a better outcome). Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points, and Combined KSS is the summed average of the Pain/Motion and Function sub-scores, leading to a Combined KSS total ranging from 0 to 200 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.	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.	KOOS consists of 5 subscales: Symptoms, Pain, Function in Daily Living, Function in Sport and Recreation, and knee related Quality of Life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given for each subscale (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score is calculated for each subscale, with a minimum of 0 indicating extreme symptoms and a maximum of 100 indicating no symptoms. Only subscale scores are reported.	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.	The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS, the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).	Pre-operative, 1, 3, and 5 years. The EQ-5D for 7 and 10 year timepoints is unavailable due to study termination.

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Romain Seil, MD, Centre Hospitalier du Luxembourg

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2012
• Primary Completion (Actual): May 28, 2020
• Study Completion (Actual): May 28, 2020

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimated): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: K-S-044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes