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

DePuy Synthes

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis

Pseudo-gout

Post-traumatic Arthritis

Gout

Treatments

Device: SIGMA HP PARTIAL KNEE

Study type

Interventional

Funder types

Industry

Identifiers

NCT01529099

CT10/01

Details and patient eligibility

About

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

Full 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.

Enrollment

64 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.