Study Stopped
Business reasons
Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses
Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting
1 other identifier
interventional
399
1 country
4
Brief Summary
The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2001
Longer than P75 for not_applicable
4 active sites
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
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
February 7, 2006
CompletedFirst Posted
Study publicly available on registry
February 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedMay 13, 2014
May 1, 2014
5.3 years
February 7, 2006
May 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Society scores
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 COMPARATORRotating Platform Cruciate Retaining Knee implant
2
ACTIVE COMPARATORRotating Platform Cruciate Substituting Knee implant.
Interventions
Rotating Platform (RP) Cruciate Retaining Knee implant
Eligibility Criteria
You may qualify if:
- Osteoarthritis
- Rheumatoid arthritis
- Avascular necrosis (AVN) of bone
- Other inflammatory arthritis
- Post-traumatic arthritis
- Juvenile rheumatoid arthritis
You may not qualify if:
- Prior ipsilateral TKA
- Metabolic disorders
- Joint replacement due to autoimmune disorders
- 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
- Severe diabetes mellitus
- Skeletal immaturity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
La Jolla, California, 92037, United States
West Coast Orthopaedic Specialists
Crystal River, Florida, 34429, United States
Unknown Facility
Melbourne, Florida, 32901, United States
Unknown Facility
Cleveland Heights, Ohio, 44118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tammy L O'Dell, EMT, CCRA
DePuy Orthopaedics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- 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
February 1, 2001
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
May 13, 2014
Record last verified: 2014-05