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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014