NCT00289094

Brief Summary

The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

March 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
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2007

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 10, 2010

Completed
Last Updated

September 13, 2022

Status Verified

July 1, 2022

Enrollment Period

6.8 years

First QC Date

February 7, 2006

Results QC Date

September 29, 2010

Last Update Submit

August 16, 2022

Conditions

OsteoarthritisRheumatoid ArthritisPost-traumatic ArthritisJuvenile Rheumatoid ArthritisAvascular Necrosis of Bone

Outcome Measures

Primary Outcomes (1)

  • Knee Society Scores

    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 (3)

  • Complications/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 (RP) Cruciate Retaining Knee System

Device: Total Knee Replacement

2

ACTIVE COMPARATOR

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

Device: Total knee replacement

Interventions

Total knee replacementDEVICE

Rotating Platform (RP) Cruciate Retaining Knee System

Also known as: P.F.C.® Sigma™ RP Cruciate Retaining Knee System
1

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 of bone

You may not qualify if:

  • Prior ipsilateral TKA
  • Metabolic disorders
  • Joint replacement due to autoimmune disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Billings, Montana, 59101, United States

Location

Unknown Facility

Vancouver, Washington, 98664, 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, Inc.
TOdell2@its.jnj.com
574-372-7104

Study Officials

  • Tammy L O'Dell, EMT, CCRA, CCRC

    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

March 1, 2001

Primary Completion

December 26, 2007

Study Completion

December 26, 2007

Last Updated

September 13, 2022

Results First Posted

December 10, 2010

Record last verified: 2022-07

Locations

US(2)