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

This study is currently recruiting participants.
Verified April 2013 by DePuy International
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01529099
First received: December 6, 2011
Last updated: April 4, 2013
Last verified: April 2013
  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, Multicentre, Multinational 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: 3 years ] [ Designated as safety issue: Yes ]
    Kaplan Meier Survival analysis at 3 years (based on revision of the femoral or tibial components)


Secondary Outcome Measures:
  • Survivorship [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: Yes ]
    Survival analyses at each post-operative assessment.

  • Knee Society Score [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment

  • KOOS [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment.

  • HAAS [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment.

  • Kujala Score [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment.

  • Oxford Knee Score [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment.

  • EQ-5D [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment.

  • Radiographic Analysis [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: Yes ]
    Change from 6 week post-operative assessment at all post-operative timepoints to identify the number of implants that are 'at risk'.


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 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 a particular type of joint replacement for people with degenerative diseases of the knee such as osteoarthritis. This type of knee replacement is called the Sigma HP® Partial Knee System and it is made by a company called DePuy International. Orthopaedic surgeons have been using this type of knee replacement for about two years. The aim of this study is to measure how this particular type of knee replacement performs over a ten year period.

Osteoarthritis (OA) is the most common form of arthritis and can affect any joint in the body. It occurs due to some type of trauma to the joint, a repeated injury to the joint, or simply due to ageing and 'wearing' of cartilage which covers and cushions the inside of a joint.

There are a number of different ways to treat OA and other degenerative diseases of the knee but commonly people have all or part of their knee joint replaced with artificial parts. The knee is made up of three compartments and arthritis can affect any number of these compartments. The Sigma HP® Partial Knee System allows a surgeon to replace only the compartments that are affected by the arthritis rather than replacing all the compartments which is what would happen in a total knee replacement. Replacing only the damaged areas maintains more of your natural knee and we think this means that more of the knee's natural movement and function can be restored. The surgery for a partial knee replacement is less invasive than for a total knee replacement and this should mean there is potential for a faster recovery.

  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: OA, 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 PFA, 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

Contacts
Contact: Sue Kemp, Ph.D +44113 3877804 skemp1@its.jnj.com

Locations
France
CHU La Cavale Blanche Withdrawn
Brest, France
Germany
Asklepios Westklinikum Hamburg Not yet recruiting
Hamburg, Germany
Principal Investigator: W Herzberg, Dr. med.         
Krankenhaus Maerkisch-Oderland Not yet recruiting
Wriezen, Germany
Italy
Orthopedic Institute IRCCS Galeazzi Withdrawn
Milan, Italy
CDC, Citta di Palma Withdrawn
Parma, Italy
Switzerland
Schulthess Klinik Recruiting
Zurich, Switzerland
Principal Investigator: S Preiss         
United Kingdom
Harrogate District Hospital Withdrawn
Harrogate, United Kingdom, HG2 7SX
Clifton Park NHS Treatment Centre Recruiting
York, United Kingdom, YO30 5RA
Contact: A Gibbon, BSc MBBS FRCS(Orth)         
Principal Investigator: A Gibbon, BSc MBBS FRCS(Orth)         
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Mr A Gibbon, BSc MBBS FRCS(Orth) Clifton Park NHS Treatment Centre
  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 4, 2013
Health Authority: United Kingdom: Department of Health
United Kingdom: Food Standards Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee
Switzerland: Ethikkommission
Switzerland: Federal Office of Public Health
Switzerland: Laws and standards
Switzerland: Swissmedic
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Germany: Federal Office for Radiation Protection
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Germany: Ministry of Work, Health and Social Affairs in North Rhine-Westph
Germany: Paul-Ehrlich-Institut
Germany: The Bavarian State Ministry of the Environment and Public Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: Ministry of Health
France: Ministère de l'Enseignement supérieur et de la Recherche
France: National Consultative Ethics Committee for Health and Life Sciences
France: The Commission nationale de l’informatique et des libertés

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
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014