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Postmarketing Study to Determine Performance of the SIGMA HP® PARTIAL KNEE SYSTEM

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ClinicalTrials.gov Identifier: NCT01529099
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
DePuy International

Tracking Information
First Submitted Date  ICMJE December 6, 2011
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date May 30, 2016
Study Start Date  ICMJE January 2009
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
Survivorship (revision) [ Time Frame: 2 years ]
Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Survivorship (revision) [ Time Frame: 3 years ]
Kaplan Meier Survival analysis at 3 years (based on revision of the femoral or tibial components)
Change History Complete list of historical versions of study NCT01529099 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
  • Survivorship [ Time Frame: 1, 2, 5 and 10 years ]
    Survival analyses at each post-operative assessment.
  • Knee Society Score [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment
  • KOOS [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • HAAS [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • Kujala Score [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • Oxford Knee Score [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • EQ-5D [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • Radiographic Analysis [ Time Frame: 1, 2, 5 and 10 years ]
    Change from 6 week post-operative assessment at all post-operative timepoints to identify the number of implants that are 'at risk'.
Current Other Pre-specified Outcome Measures
 (submitted: May 27, 2016)
  • Types and Frequency of Adverse Events [ Time Frame: Throughout the study ]
  • Clinical outcome using the AKS score [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  • Patient-reported outcome using the KOOS assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  • Patient-reported outcome using the HAAS assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  • Patient-reported outcome using the Kujala score [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  • Patient-reported outcome using the Oxford Knee Score [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  • Patient-reported outcome using the EQ-5D assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  • Radiographic assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postmarketing Study to Determine Performance of the SIGMA HP® PARTIAL KNEE SYSTEM
Official Title  ICMJE A Prospective, Non-comparative, Single Centre Study to Determine the Performance & Survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
Brief Summary This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
Detailed Description The purpose of this study is to collect more information about the Sigma HP® Partial Knee System made by DePuy International. The aim of this study is to measure how this particular type of knee replacement performs over a two year period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Post-traumatic Arthritis
  • Gout
  • Pseudo-gout
Intervention  ICMJE Device: SIGMA HP PARTIAL KNEE
SIGMA HP PARTIAL KNEE
Other Names:
  • Sigma HP Partial Knee Femoral component
  • Sigma HP Partial Knee Tibial component
  • Sigma HP Partial Knee Tibial insert component
  • Sigma Patellae
  • Sigma HP Partial Knee Trochlear component
Study Arms  ICMJE Experimental: Sigma HP Partial Knee
Partial knee replacement
Intervention: Device: SIGMA HP PARTIAL KNEE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2015)
64
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2012)
200
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects, aged at least 21 years.
  • 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.
  • Subject has non-inflammatory degenerative joint disease (NIDJD), including: osteoarthritis, posttraumatic arthritis, avascular necrosis and chondrocalcinosis.
  • Subject has a functional stable knee.
  • Subject, in the opinion of the Investigator, is suitable for either a single or bicompartmental knee replacement.
  • Subject meets the following selected radiographic parameters:

    • X-ray evaluation confirms the presence of NIDJD
    • Disease location: 1 to 2 compartments, maximum. Disease can be present in the patellofemoral compartment, the medial tibiofemoral compartment, lateral tibiofemoral compartments alone or in any two compartments.
    • Disease severity: Kellgren and Lawrence44 Grade II or greater for all compartments replaced.

Exclusion Criteria:

  • 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.
  • Women who are pregnant.
  • 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 3 months.
  • Subjects who are currently involved in any injury litigation claims.
  • Multiple joint involvement that will compromise rehabilitation (for example: advanced hip, ankle or spine disease).
  • Known to be a prisoner, mentally incompetent, an alcohol / drug abuser, involved in medical-legal case or worker's compensation
  • Previous knee arthroplasty (any type) in any one of the three compartments of the knee.
  • Requires more than a lateral soft tissue release or an anterior cruciate ligament reconstruction.
  • Uncorrectable anatomical tibio-femoral angle.
  • Bone deficiency requiring structural bone grafts to support the implants.
  • Previous patellectomy.
  • For Subjects indicated for a patellofemoral arthroplasty, Subject has uncorrected patella baja (Caton-Deschamps ratio less than or equal to 0.6).
  • Tri-compartmental disease process (patella-femoral, medial tibio-femoral and lateral tibio-femoral).
  • Active bacterial infection that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of knee joint, urinary tract infection, etc.).
  • Significant neurological or musculoskeletal deformity or a disease that may affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis, amputation).
  • Known allergy to implant materials.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Switzerland
Removed Location Countries France,   Germany,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01529099
Other Study ID Numbers  ICMJE CT10/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DePuy International
Study Sponsor  ICMJE DePuy International
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DePuy International
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP