Back to resultsShould my New Knee Rotate?
Primary Purpose
Arthritis of the Knee Joint
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
mobile bearing knee system for total knee arthroplasty
fixed bearing total knee prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis of the Knee Joint focused on measuring mobile bearing knee prosthesis
Eligibility Criteria
Inclusion Criteria:
- Patients requiring cemented primary total knee replacement.
- Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (TA)
- Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation.
- Patient who have intact collateral ligaments.
- Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.
Exclusion Criteria:
- Patient where patella will not be resurfaced.
- Patients with active or suspected infection.
- Patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
- The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weightbearing or places an extreme load on the implant during the healing period.
- Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mobile bearing knee prosthesis
fixed bearing
Arm Description
use of the Scorpio mobile bearing knee system for total knee arthroplasty
use of the Scorpio fixed bearing knee system for total knee arthoplasty
Outcomes
Primary Outcome Measures
Anterior knee pain during stair rise
Anterior knee pain using VAS during stair rise at different follow up moments until 5 years after surgery
Anterior knee pain during stair climb
Anterior knee pain using VAS during stair climb at different FU moments
Secondary Outcome Measures
passive and active Range of motion
measuring passive and active range of motion (flexion / extension) using a goniometer at different FU moments
patella compression pain
patella compression pain at physical examination at different FU moments defined as yes of no when putting mild pressure on the patella
patient satisfaction
measuring patient satisfaction using the RAND-36 questionnaire at different FU moments
Full Information
NCT ID
NCT02892838
First Posted
September 2, 2016
Last Updated
April 25, 2018
Sponsor
Maastricht University Medical Center
Collaborators
Stryker Nordic
1. Study Identification
Unique Protocol Identification Number
NCT02892838
Brief Title
Should my New Knee Rotate?
Official Title
Should my New Knee Rotate? A Randomised, Controlled Clinical Trial to Compare Fixed and Mobile Bearing Total Knee Arthroplasties Using the SCORPIO PS and SCORPIO+ PS Knee Systems
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Stryker Nordic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Total Knee Arthroplasty (TKA) is the surgical reconstruction of the knee joint in order to relieve pain, restore function and correct deformity. It is a very common surgical procedure with figures showing more than 500'000 arthroplasties performed annually worldwide. Total knee arthroplasty is considered one of the most successful types of joint reconstruction in that surgical results usually meet and even exceed expectations. Much of the current literature focuses on the issues relating to implant wear as a potential failure mode for artificial knee implants. It has been suggested that knee with mobile or rotating bearing options, such as the comparative device proposed for this clinical investigation, may survive longer than fixed bearing knee designs because of the greater contact surface area possible with more congruent components with unconstrained, mobile component design.
Detailed Description
This is a prospective, comparative, randomised, open-label, single center, multiple surgeons clinical study. The Scorpio PS Superflex and the Scorpio PS mobile bearing are to be implanted for evaluation in this study. Patients will be randomised to one of two equal sized groups. In the first group patients will be treated with the Scorpio PS Superflex, whilst in the second group patients will be treated with the Scorpio PS mobile bearing implant.
Evaluations consist of the KSS score, Chair rise and stair climb tests, radiology assessments, patient questionnaires, at multiple timepoints: pre-operative, 6 weeks, 3 months, 6 months 1 year, 2 years and 5 years post-operatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis of the Knee Joint
Keywords
mobile bearing knee prosthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mobile bearing knee prosthesis
Arm Type
Experimental
Arm Description
use of the Scorpio mobile bearing knee system for total knee arthroplasty
Arm Title
fixed bearing
Arm Type
Active Comparator
Arm Description
use of the Scorpio fixed bearing knee system for total knee arthoplasty
Intervention Type
Device
Intervention Name(s)
mobile bearing knee system for total knee arthroplasty
Intervention Type
Device
Intervention Name(s)
fixed bearing total knee prosthesis
Primary Outcome Measure Information:
Title
Anterior knee pain during stair rise
Description
Anterior knee pain using VAS during stair rise at different follow up moments until 5 years after surgery
Time Frame
5 years
Title
Anterior knee pain during stair climb
Description
Anterior knee pain using VAS during stair climb at different FU moments
Time Frame
5 years
Secondary Outcome Measure Information:
Title
passive and active Range of motion
Description
measuring passive and active range of motion (flexion / extension) using a goniometer at different FU moments
Time Frame
5 years
Title
patella compression pain
Description
patella compression pain at physical examination at different FU moments defined as yes of no when putting mild pressure on the patella
Time Frame
5 years
Title
patient satisfaction
Description
measuring patient satisfaction using the RAND-36 questionnaire at different FU moments
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients requiring cemented primary total knee replacement.
Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (TA)
Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation.
Patient who have intact collateral ligaments.
Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.
Exclusion Criteria:
Patient where patella will not be resurfaced.
Patients with active or suspected infection.
Patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weightbearing or places an extreme load on the implant during the healing period.
Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Feczko, MD
Organizational Affiliation
orthopedic surgeon MUMC Maastricht
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28662692
Citation
Feczko PZ, Jutten LM, van Steyn MJ, Deckers P, Emans PJ, Arts JJ. Comparison of fixed and mobile-bearing total knee arthroplasty in terms of patellofemoral pain and function: a prospective, randomised, controlled trial. BMC Musculoskelet Disord. 2017 Jun 29;18(1):279. doi: 10.1186/s12891-017-1635-9.
Results Reference
derived
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