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

NCT ID: NCT01529099

Last Updated: 2016-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-07-31

Brief Summary

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

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.

Conditions

Osteoarthritis; Post-traumatic Arthritis; Gout; Pseudo-gout

Keywords

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.

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sigma HP Partial Knee

Partial knee replacement

Group Type: EXPERIMENTAL

SIGMA HP PARTIAL KNEE

Intervention Type: DEVICE

SIGMA HP PARTIAL KNEE

Interventions

SIGMA HP PARTIAL KNEE

SIGMA HP PARTIAL KNEE

Intervention Type: DEVICE

Other Intervention 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

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orthopedic Institute IRCCS Galeazzi

Milan, , Italy

CDC, Citta di Palma

Parma, , Italy

Schulthess Klinik

Zurich, , Switzerland

Countries

France; Germany; United Kingdom; Italy; Switzerland

Other Identifiers

CT10/01

Identifier Type: -

Identifier Source: org_study_id