NCT00733369

Brief Summary

The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA. The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior Stabilised (PS) Knee over 5 years.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
25 days until next milestone

Results Posted

Study results publicly available

August 26, 2014

Completed
Last Updated

September 13, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

August 12, 2008

Results QC Date

March 22, 2014

Last Update Submit

August 1, 2016

Conditions

Knee Osteoarthritis

Keywords

ArthroplastyReplacementKneePFC Sigma RPFPFC Sigma RP

Outcome Measures

Primary Outcomes (1)

  • Change From Pre-op to 1 Year Range of Motion.

    Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.

    1 year

Secondary Outcomes (55)

  • To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.

    3-6 months

  • To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.

    1 year

  • To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.

    2 years

  • To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.

    5 years

  • To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.

    3-6 months

  • +50 more secondary outcomes

Study Arms (2)

PFC Sigma RP-F

OTHER

125 patients to be allocated to this arm according to blinding envelopes

Device: PFC Sigma RP-F

PFC Sigma RP

ACTIVE COMPARATOR

125 patients to be allocated to this arm according to blinding envelopes

Device: PFC Sigma RP

Interventions

PFC Sigma RP-FDEVICE

An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing

PFC Sigma RP-F
PFC Sigma RPDEVICE

An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing

PFC Sigma RP

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 clinical investigation and from whom consent has been obtained.
  • Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical 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 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 either the P.F.C Sigma RP-F or the P.F.C Sigma RP knee, according to the indications specified in the package insert leaflet.
  • Subjects who have authorised the transfer of his/her pseudonymised information to DePuy.

You may not qualify if:

  • Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
  • Female subjects who are pregnant or lactating.
  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • Subjects who have participated in a clinical investigation with an investigational product in the last month( 30 days).
  • Subjects who are currently involved in any injury litigation claims.
  • Subjects with a known history of poor compliance to medical treatment.
  • Subjects who have previously had an osteotomy or significant surgery in the affected knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Location

Arrowe Park Hospital

Metropolitan Borough of Wirral, Mersyside, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Kimberly Dwyer, PhD, CCRA
Organization
DePuy Ortho Joint US
kdwyer2@its.jnj.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 13, 2008

Study Start

November 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2014

Last Updated

September 13, 2016

Results First Posted

August 26, 2014

Record last verified: 2016-08

Locations

GB(1)ES(1)