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Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses

Sponsor
DePuy Orthopaedics (Industry)
Overall Status
Terminated
CT.gov ID
NCT00289081
Collaborator
(none)
399
Enrollment
4
Locations
2
Arms
63.9
Duration (Months)
99.8
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Total Knee Replacement
  • Device: Total knee replacement
 N/A

Detailed Description

The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.

Study Design

Study Type:
Interventional
Actual Enrollment :
399 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting
Study Start Date :
Feb 1, 2001
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Jun 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Rotating Platform Cruciate Retaining Knee implant

Device: Total Knee Replacement
Rotating Platform (RP) Cruciate Retaining Knee implant
Other Names:
  • P.F.C.® Sigma™ RP Cruciate Retaining Knee implant

    		•
    Active Comparator: 2

    Rotating Platform Cruciate Substituting Knee implant.

    Device: Total knee replacement
    Rotating Platform (RP) Cruciate Substituting Knee implant.
    Other Names:
  • P.F.C.® Sigma™ RP Cruciate Substituting Knee implant.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Knee Society scores [Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.]

    Secondary Outcome Measures

    1. Complications [On-going to end of study]

    2. Revisions [On-going to end of study]

    3. Medical imaging [Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.]

    4. SF-12 patient outcomes [Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Osteoarthritis

    • Rheumatoid arthritis

    • Avascular necrosis (AVN) of bone

    • Other inflammatory arthritis

    • Post-traumatic arthritis

    • Juvenile rheumatoid arthritis

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 La Jolla California United States 92037
    2 West Coast Orthopaedic Specialists Crystal River Florida United States 34429
    3 Melbourne Florida United States 32901
    4 Cleveland Heights Ohio United States 44118

    Sponsors and Collaborators

    • DePuy Orthopaedics

    Investigators

    • Study Director: Tammy L O'Dell, EMT, CCRA, DePuy Orthopaedics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DePuy Orthopaedics
    ClinicalTrials.gov Identifier:
    NCT00289081
    Other Study ID Numbers:
    • SRP-1
    First Posted:
    Feb 9, 2006
    Last Update Posted:
    May 13, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by DePuy Orthopaedics
    Total Knee Replacement
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Osteonecrosis
    Necrosis

    Study Results

    No Results Posted as of May 13, 2014