Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00761410




Registration number
NCT00761410
Ethics application status
Date submitted
26/09/2008
Date registered
29/09/2008
Date last updated
20/06/2016

Titles & IDs
Public title
A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
Scientific 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.
Secondary ID [1] 0 0
CT0153
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - P.F.C. Sigma RP-F Total Knee Replacement

Other: P.F.C. Sigma RP-F Total Knee Replacement - An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design


Treatment: Devices: P.F.C. Sigma RP-F Total Knee Replacement
An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater.
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years.
Timepoint [1] 0 0
1, 2, 3 and 5 years
Secondary outcome [2] 0 0
American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years
Timepoint [2] 0 0
1, 2, 3 and 5 years
Secondary outcome [3] 0 0
Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years
Timepoint [3] 0 0
1, 2, 3 and 5 years
Secondary outcome [4] 0 0
Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years
Timepoint [4] 0 0
1, 2, 3 and 5 years
Secondary outcome [5] 0 0
Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years
Timepoint [5] 0 0
1, 2, 3 and 5 years
Secondary outcome [6] 0 0
SF-12 1, 2, 3, 5, 10, 15 and 20 years
Timepoint [6] 0 0
1, 2, 3 and 5 years

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Maharashtra
Country [2] 0 0
Japan
State/province [2] 0 0
Kobe
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington
Country [5] 0 0
Singapore
State/province [5] 0 0
Tan Tock Seng
Country [6] 0 0
Thailand
State/province [6] 0 0
Bangkok
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Nottingham
Country [8] 0 0
United Kingdom
State/province [8] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DePuy International
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00761410
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00761410