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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: Scorpio PS (posterior stable); Device: Scorpio NRG PS

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Central Trial Center Maastricht BV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients requiring a primary total knee arthroplasty (TKA)
• Male and nonpregnant female patients
• Between 18 and 80 years of age at time of surgery
• Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN), and not severe posttraumatic arthritis
• No previous osteosynthesis of the involved knee during the last 12 months
• Patients who understand the conditions of the study and are wiling to participate for the length of the described follow up
• Patients who are capable of, and have given, informed consent for participation in the study

Exclusion Criteria:

• Patients requiring revision surgery of a previous implanted total knee system
• Patients with a diagnosis of severe posttraumatic arthritis (TA) and rheumatoid arthritis (RA)
• Patients with active infection
• Patients with malignancy
• Patients with an immobile hip or ankle arthrodesis
• Severe obese patients (BMI > 35)
• Patients with a neurological deficit
• Previous history of unicompartmental knee arthroplasty or patellar prosthesis
• Patients with concurrent illnesses which are likely to affect their outcome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Scorpio PS; Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement.	Device: Scorpio PS (posterior stable); Implantation of total knee prosthesis
Active Comparator: Scorpio NRG PS; Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement.	Device: Scorpio NRG PS; Implantation of total knee prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Maximum Passive and Active Flexion.	Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis. The active flexion-tolerated range is greater/equal 70 degree. The passive flexion-tolerated range is greater/equal 80 degree. The Hyperextension tolerated range is 0 to 10 degree. Higher scores mean a better outcome.	5 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.	pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
Chair Raise Test	A measurement to assess functional lower extremity strength. The participant is seated on a chair. Arms are crossed at the wrists and held against the chest. The participant is instructed to arise from an adjustable chair with the knees in a 90 degree angle (measurement with Goniometer) without using arms.	pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
WOMAC Patient Questionnaire	The WOMAC collects information specific to osteoarthritis outcomes. The patient response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limited in function, and 4 indicating extreme pain stiffness, or limited in function. Total WOMAC scores range from 0 to 96 wit lower values representing better outcomes.	pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire	The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. 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.	pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Peter Feczko, MD, Clinical Trial Center Maastricht BV

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: August 7, 2015
• First Posted (Estimated): August 13, 2015

Study Record Updates

• Last Update Posted (Estimated): 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: 20100506 /K-S-006