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

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

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, Senior)
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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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	DePuy International
ClinicalTrials.gov Identifier:	NCT01529099 History of Changes
Other Study ID Numbers:	CT10/01
First Posted:	February 8, 2012
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