NCT00289107

Brief Summary

The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

April 1, 2001

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

December 10, 2010

Completed
Last Updated

May 3, 2023

Status Verified

March 1, 2023

Enrollment Period

6.6 years

First QC Date

February 7, 2006

Results QC Date

September 29, 2010

Last Update Submit

April 4, 2023

Conditions

OsteoarthritisRheumatoid ArthritisOther Inflammatory ArthritisPost-Traumatic ArthritisJuvenile Rheumatoid ArthritisAvascular Necrosis

Keywords

Total Knee ReplacementKnee Prosthesis

Outcome Measures

Primary Outcomes (1)

  • Knee Society Score

    The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.

    Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Secondary Outcomes (4)

  • Complications

    On-going to end of study

  • Revisions

    On-going to end of study

  • Medical Imaging

    Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

  • SF-12 Patient Outcomes

    Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Study Arms (2)

1

ACTIVE COMPARATOR

P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System

Device: Total Knee Arthroplasty

2

ACTIVE COMPARATOR

P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System

Device: Total knee replacement

Interventions

Total Knee ArthroplastyDEVICE

Rotating Platform (RP) Cruciate Substituting Knee System

Also known as: P.F.C.® Sigma™ RP Cruciate Substituting Knee System
1
Total knee replacementDEVICE

Fixed Cruciate Substituting Knee System

Also known as: P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System
2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritis
  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Avascular necrosis (AVN) of bone
  • Post-Traumatic Arthritis
  • Juvenile Rheumatoid Arthritis

You may not qualify if:

  • History of recent/active joint sepsis.
  • Charcot neuropathy.
  • Psycho-social disorders that would limit rehabilitation.
  • Greater than 75 years of age at the time of surgery.
  • Prior ipsilateral knee arthroplasty.
  • Metabolic disorders of calcified tissues, such as Paget's disease.
  • Severe diabetes mellitus.
  • Joint replacement due to autoimmune disorders.
  • Skeletal immaturity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Greensboro, North Carolina, 27408, United States

Location

Unknown Facility

Austin, Texas, 78746, United States

Location

Unknown Facility

Lakewood, Washington, 98499, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidArthritis, JuvenileOsteonecrosis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Results Point of Contact

Title
Tammy O'Dell, EMT, CCRA
Organization
DePuy Orthopaedics
TOdell2@its.jnj.com
574-372-7104

Study Officials

  • Tammy L O'Dell, EMT, CCRA

    DePuy Orthopaedics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 9, 2006

Study Start

April 1, 2001

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 3, 2023

Results First Posted

December 10, 2010

Record last verified: 2023-03

Locations

US(3)