NCT02520531

Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty

Scorpio PS vs Scorpio NRG PS - Total Knee Arthroplasty Comparative Investigation of Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications.

Detailed description

Surveillance design: Single-centre, prospective, randomized comparative study. Objectives: To compare the maximum flexion (active and passive) and Chair Raise achievement ratios. All complications will be documented. Number of subjects to be enrolled: All consecutive Scorpio patients are included until a group size of 88 is reached. Clinical evaluations: Chair raise test, Stair climb test, Western Ontario McMaster Osteoarthritis Index (WOMAC) patient self evaluation, EuroQuol - 5 dimension (EQ-5D) patient questionnaire. Standard clinical, functional and pain parameters (Knee Society Score), pre-operatively and post-operatively. All per- and post-op complications.

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DEVICE	Scorpio PS (posterior stable)	Implantation of total knee prosthesis
DEVICE	Scorpio NRG PS	Implantation of total knee prosthesis

Timeline

• Start date: 2010-09-01
• Primary completion: 2018-06-28
• Completion: 2018-06-28
• First posted: 2015-08-13
• Last updated: 2024-02-22
• Results posted: 2019-09-20

Locations

1 site across 1 country: Netherlands