Clinical trial NCT00761410: A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
Official title: A Prospective, Non-Comparative Multi Centre Study to Evaluate the Clinical Performance of the DePuy Press Fit Condylar (P.F.C.) Sigma Rotating Platform High Flexion Knee.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Arthroplasty
Knee
Replacement
High Flexion
PFC Sigma RP-F
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 170
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater.
timeFrame: 1 year
Secondary outcomes:
measure: Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years.
timeFrame: 1, 2, 3 and 5 years
measure: American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years
timeFrame: 1, 2, 3 and 5 years
measure: Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years
timeFrame: 1, 2, 3 and 5 years
measure: Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years
timeFrame: 1, 2, 3 and 5 years
measure: Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years
timeFrame: 1, 2, 3 and 5 years
measure: SF-12 1, 2, 3, 5, 10, 15 and 20 years
timeFrame: 1, 2, 3 and 5 years
Other outcomes:
Locations:
city: Mumbai
country: India
facility: The Nook, 51/B SV Road
state: Maharashtra
city: Chuoku
country: Japan
facility: Kobe University Graduate School Of Medicine, 7-5-1 Kusundki- cho
state: Kobe
city: Dongdaemun Gu
country: Korea, Republic of
facility: Kyunghee University Hospital, 1 HoegiDong
state: Seoul
city: Newtown
country: New Zealand
facility: Wellington School Of Medicine Surgical Research Trust, Main Street
state: Wellington
city: Tan Tock Seng
country: Singapore
facility: Tan Tock Seng Hospital, No 11 Jalan
city: Bangkok
country: Thailand
facility: Sirriraj Hospital, Mahidol University
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital, Hucknell Road
city: York
country: United Kingdom
facility: Clifton Park NHS Treatment Centre, Blue Beck Drive, Shipton Road
Study officials:
References: