Arthritis of the Knee Joint Clinical Trial
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
| Verified date | July 2016 |
| Source | Maastricht University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | December 2011 |
| Est. primary completion date | November 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center | Stryker Nordic |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Anterior knee pain during stair rise | Anterior knee pain using VAS during stair rise at different follow up moments until 5 years after surgery | 5 years | |
| Primary | Anterior knee pain during stair climb | Anterior knee pain using VAS during stair climb at different FU moments | 5 years | |
| Secondary | passive and active Range of motion | measuring passive and active range of motion (flexion / extension) using a goniometer at different FU moments | 5 years | |
| Secondary | 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 | 5 years | |
| Secondary | patient satisfaction | measuring patient satisfaction using the RAND-36 questionnaire at different FU moments | 5 years |