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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01529099
First received: December 6, 2011
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.


Condition Intervention Phase
Osteoarthritis
Post-traumatic Arthritis
Gout
Pseudo-gout
Device: SIGMA HP PARTIAL KNEE
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Non-comparative, Single Centre Study to Determine the Performance & Survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Survivorship (revision) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)


Other Outcome Measures:
  • Types and Frequency of Adverse Events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sigma HP Partial Knee 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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529099

Locations
Switzerland
Schulthess Klinik
Zurich, Switzerland
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Dr. Stefan Preiss, MD Schulthess Klinik
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT01529099     History of Changes
Other Study ID Numbers: CT10/01
Study First Received: December 6, 2011
Last Updated: April 22, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Federal Office of Public Health
Switzerland: Laws and standards
Switzerland: Swissmedic

Keywords provided by DePuy International:
Osteoarthritis
Knee
Knee replacement
Knee implant
Knee arthroplasty
Unicompartmental
Primary
Partial
Patellofemoral
Medial
Lateral
Bicompartmental
Cemented
Post-traumatic arthritis of the tibio-femoral and/or patellofemoral articular surfaces
History of Gout or pseudo-gout.

Additional relevant MeSH terms:
Arthritis
Gout
Osteoarthritis
Chondrocalcinosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014