The purpose of this study is to gather information about total knee replacement surgery using P.F.C Sigma RP-F device and collect a long-term clinical outcome data.

Phase 4

Completed

Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecified

Registration Number: CTRI/2007/091/000038

Lead Sponsor: Johnson and Johnson Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 280

Inclusion Criteria

1) Male or female subjects, aged between 45 and 75 years inclusive.

2) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

3)Subjects who are able to achieve a pre-operative passive range of motion of equal to greater than 125 degrees

4)Subjects who, in the opinion of the investigator, are able to understand this investigation, cooperate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups

5)Subjects who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.

6)Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the P.F.C Sigma RP-F knee, according to the indications specified in the package insert leaflet.

Exclusion Criteria

1)Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
2)Women who are pregnant.
3)Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
4)Subjects who have participated in a clinical study with an investigational product in the last month(30 days)
5)Subjects who are currently involved in any personal injury litigation claims.
6)Subjects with a known history of poor compliance to medical treatment.
7)Subjects who have a pre-operative limb deformity of equal to or greater than 10 degree varus or 15 degree valgus as defined using the anatomical axis.
8)Subjects who have morbid obesity i.e BMI more than equal to 40
9)Subjects who wish to have a simultaneous bilateral procedure.However,subjects who have had a staged bilateral procedure may be included as long as the previous procedure was performed 9 or more months prior to their inclusion in the study.