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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Implantation of total knee prosthesis
Implantation of total knee prosthesis
Central Trial Center Maastricht BV
Maastricht, Limburg, Netherlands
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.
Time frame: 5 years follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up