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

A Prospective, Non-comparative, Single Centre Study to Determine the Performance & Survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Post-traumatic Arthritis; Gout; Pseudo-gout
• Intervention / Treatment: Device: SIGMA HP PARTIAL KNEE

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Orthopedic Institute IRCCS Galeazzi
  • Parma, Italy
    • CDC, Citta di Palma
• Switzerland
  • Zurich, Switzerland
    • Schulthess Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship (revision)	Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)	2 years

Other Outcome Measures

Outcome Measure	Time Frame
Types and Frequency of Adverse Events	Throughout the study
Clinical outcome using the AKS score	6 weeks, 6 months, 1 year and 2 years post-op
Patient-reported outcome using the KOOS assessment	6 weeks, 6 months, 1 year and 2 years post-op
Patient-reported outcome using the HAAS assessment	6 weeks, 6 months, 1 year and 2 years post-op
Patient-reported outcome using the Kujala score	6 weeks, 6 months, 1 year and 2 years post-op
Patient-reported outcome using the Oxford Knee Score	6 weeks, 6 months, 1 year and 2 years post-op
Patient-reported outcome using the EQ-5D assessment	6 weeks, 6 months, 1 year and 2 years post-op
Radiographic assessment	6 weeks, 6 months, 1 year and 2 years post-op

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 30, 2016
• Last Update Submitted That Met QC Criteria: May 27, 2016
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Knee replacement; Patellofemoral; Knee arthroplasty; Primary; Cemented; Bicompartmental; Medial; Partial; Unicompartmental; Knee implant; Lateral; Post-traumatic arthritis of the tibio-femoral and/or patellofemoral articular surfaces; History of Gout or pseudo-gout.
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Arthritis; Osteoarthritis; Gout; Chondrocalcinosis
• Other Study ID Numbers: CT10/01