Osteoarthritis
Conditions
Keywords
Arthroplasty, Knee, Replacement, High Flexion, PFC Sigma RP-F
Brief summary
The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.
Detailed description
Primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater. The secondary endpoint is to investigate the survivorship of the P.F.C. Sigma RP-F knee at 1, 2, 3, 5, 10, 15 and 20 years
Interventions
DEVICEP.F.C. Sigma RP-F Total Knee Replacement
An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design
Sponsors
DePuy International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, aged between 45 and 75 years inclusive. * Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. * Subjects who are able to achieve a pre-operative passive range of motion of equal to or greater than 110º. * Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. * Subjects who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty. * Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the P.F.C.® Sigma RPF knee, according to the indications specified in the package insert leaflet.
Exclusion criteria
* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. * Women who are pregnant. * Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. * Subjects who have participated in a clinical study with an investigational product in the last month (30 days). * Subjects who are currently involved in any personal injury litigation claims. * Subjects with a known history of poor compliance to medical treatment. * Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis. * Subjects who have morbid obesity i.e. BMI ≥40.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater. | 1 year | Proportion of cases that have a functionally stable knee (Q10 of Oxford Knee Score is 'rarely/never' or 'sometimes, or just at first'), AND can achieve 1-year post-op passive range of motion of 125 degrees or greater. |
Secondary
| Measure | Time frame |
|---|---|
| American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years | 1, 2, 3 and 5 years |
| Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years | 1, 2, 3 and 5 years |
| Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years. | 1, 2, 3 and 5 years |
| Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years | 1, 2, 3 and 5 years |
| SF-12 1, 2, 3, 5, 10, 15 and 20 years | 1, 2, 3 and 5 years |
| Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years | 1, 2, 3 and 5 years |
Countries
India, Japan, New Zealand, Singapore, South Korea, Thailand, United Kingdom
Outcome results
None listed