Trials / Completed
CompletedNCT02524730
Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study
Scorpio NRG Prospective, Open-label, Post-market International Multicentre Outcome Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 205 (actual)
- Sponsor
- Stryker Orthopaedics · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.
Detailed description
Evaluation of the effect of the component design on functional performance by comparing postoperative Knee Society Scores (KSS) with preoperative. Evaluate post-operative radiographic findings. Evaluate the effect of component design on patient activity by comparing postoperative Lower Extremity Activity Scale (LEAS) with preoperative. Evaluate patient satisfaction using Short-Form-36 Health Survey (SF-36). Evaluate quality of life using Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQuol-5 dimension patient questionaire (EQ-5D).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Primary total knee replacement (Scorpio NRG CR Total Knee System) | Scorpio NRG CR Total Knee System |
Timeline
- Start date
- 2009-05-18
- Primary completion
- 2020-02-10
- Completion
- 2020-02-10
- First posted
- 2015-08-17
- Last updated
- 2024-02-22
- Results posted
- 2021-06-14
Locations
5 sites across 4 countries: Austria, Germany, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02524730. Inclusion in this directory is not an endorsement.