Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, knee
Treatments scorpio ps (posterior stable), scorpio nrg ps
Sponsor Stryker European Operations BV
Start date September 2010
End date November 2018
Trial size 88 participants
Trial identifier NCT02520531, 20100506 /K-S-006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
scorpio ps (posterior stable)
Implantation of total knee prosthesis
(Active Comparator)
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.
scorpio nrg ps
Implantation of total knee prosthesis

Primary Outcomes

Measure
Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis.
time frame: 5 years follow-up

Secondary Outcomes

Measure
Knee Society Score (KSS)
time frame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
Chair Raise Test
time frame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
WOMAC patient questionnaire
time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
EQ-5D patient questionnaire
time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Patients requiring a primary total knee aarthroplasty (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

Additional Information

Official title Scorpio PS vs Scorpio NRG PS - Total Knee Arthroplasty Comparative Investigation of Function
Principal investigator Peter Feczko, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Stryker European Operations BV.