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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

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

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : January 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : July 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sigma HP Partial Knee
Partial knee replacement
 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


Outcome Measures
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Primary Outcome Measures :
  1. Survivorship (revision) [ Time Frame: 2 years ]
    Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)


Other Outcome Measures:
  1. Types and Frequency of Adverse Events [ Time Frame: Throughout the study ]
  2. Clinical outcome using the AKS score [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  3. Patient-reported outcome using the KOOS assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  4. Patient-reported outcome using the HAAS assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  5. Patient-reported outcome using the Kujala score [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  6. Patient-reported outcome using the Oxford Knee Score [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  7. Patient-reported outcome using the EQ-5D assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]
  8. Radiographic assessment [ Time Frame: 6 weeks, 6 months, 1 year and 2 years post-op ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529099


Locations
Italy
Orthopedic Institute IRCCS Galeazzi
Milan, Italy
CDC, Citta di Palma
Parma, Italy
Switzerland
Schulthess Klinik
Zurich, Switzerland
Sponsors and Collaborators
DePuy International
More Information
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Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT01529099     History of Changes
Other Study ID Numbers: CT10/01
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: June 2015

Keywords provided by DePuy International:
History of Gout or pseudo-gout.
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

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