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

Phase 4

Completed

• Conditions: Pseudo-gout; Osteoarthritis; Gout; Post-traumatic Arthritis

• Registration Number: NCT01529099
• Lead Sponsor: DePuy International

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-08
• Primary Completion: 2015-01
• Status Verified: 2015-06
• Study Completion: 2015-07
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survivorship (revision)	2 years	Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)

Trial Locations

Locations (3)

Orthopedic Institute IRCCS Galeazzi; 🇮🇹 Milan, Italy

CDC, Citta di Palma; 🇮🇹 Parma, Italy

Schulthess Klinik; 🇨🇭 Zurich, Switzerland