Arthroplasty, Replacement, Knee Clinical Trial
— ScorpioNRGPSOfficial title:
Scorpio PS vs Scorpio NRG PS - Total Knee Arthroplasty Comparative Investigation of Function
Verified date | February 2024 |
Source | Stryker Orthopaedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | June 28, 2018 |
Est. primary completion date | June 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Central Trial Center Maastricht BV | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Stryker Orthopaedics |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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