A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System

NCT00761410 | Terminated Phase 4

• 1 other identifier: CT0153
• Study Type: interventional
• Target: 170
• Locations: 7 countries
• Sites: 8

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.

Conditions

Osteoarthritis

Keywords

Arthroplasty; Knee; Replacement; High Flexion; PFC Sigma RP-F

Outcome Measures

Primary Outcomes (1)

• Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater.

  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.

  1 year

Secondary Outcomes (6)

• 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

• 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

• Oxford Knee Score 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

Study Arms (1)

P.F.C. Sigma RP-F Total Knee Replacement

OTHER

An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design

Device: P.F.C. Sigma RP-F Total Knee Replacement

Interventions

P.F.C. Sigma RP-F Total Knee Replacement DEVICE

An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design

P.F.C. Sigma RP-F Total Knee Replacement

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (8)

The Nook, 51/B SV Road

Mumbai, Maharashtra, 400 054, India

Location

Kobe University Graduate School Of Medicine, 7-5-1 Kusundki- cho

Chūōku, Kobe, Japan

Location

Wellington School Of Medicine Surgical Research Trust, Main Street

Newtown, Wellington Region, New Zealand

Location

Tan Tock Seng Hospital, No 11 Jalan

Tan Tock Seng, 308433, Singapore

Location

Kyunghee University Hospital, 1 HoegiDong

Dongdaemun Gu, Seoul, South Korea

Location

Sirriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Nottingham City Hospital, Hucknell Road

Nottingham, NG5 1PB, United Kingdom

Location

Clifton Park NHS Treatment Centre, Blue Beck Drive, Shipton Road

York, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 29, 2008
• Study Start: October 1, 2004
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2015
• Last Updated: June 20, 2016

Record last verified: 2016-06

Locations

JP (1); KR (1); NZ (1); SG (1); TH (1); GB (2); IN (1)