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

Stryker

Status: Terminated

Conditions: Arthroplasty, Replacement, Knee

Treatments: Device: Triathlon Total Knee System with X3 insert; Device: Triathlon PKR System with X3 insert; Device: Scorpio NRG Total Knee System with X3 insert; Procedure: Partial Knee Resurfacing; Procedure: Total Knee Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT02525562

K-S-044

Details and patient eligibility

About

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)

Full 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).

Enrollment: 237 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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237 participants in 3 patient groups

Scorpio NRG Total Knee System

Other group

Description:

Patients eligible for Scorpio NRG Total Knee System with X3 insert

Treatment:

Procedure: Total Knee Replacement

Device: Scorpio NRG Total Knee System with X3 insert

Triathlon Total Knee System

Other group

Description:

Patients eligible for Triathlon Total Knee System with X3 insert

Treatment:

Procedure: Total Knee Replacement

Device: Triathlon Total Knee System with X3 insert

Triathlon Partial Knee Resurfacing

Other group

Description:

Patients eligible for Triathlon PKR System with X3 insert

Treatment:

Procedure: Partial Knee Resurfacing

Device: Triathlon PKR System with X3 insert