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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529099
• Other study ID #: CT10/01
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2011
• Last updated: May 27, 2016
• Start date: January 2009
• Est. completion date: July 2015

Study information

• Verified date: June 2015
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Federal Office of Public HealthSwitzerland: Laws and standardsSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chondrocalcinosis
• Gout
• Osteoarthritis
• Post-traumatic Arthritis
• Pseudo-gout

Intervention

Device:
• SIGMA HP PARTIAL KNEE
SIGMA HP PARTIAL KNEE

Locations

Country	Name	City	State
Italy	Orthopedic Institute IRCCS Galeazzi	Milan
Italy	CDC, Citta di Palma	Parma
Switzerland	Schulthess Klinik	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Types and Frequency of Adverse Events		Throughout the study	Yes
Other	Clinical outcome using the AKS score		6 weeks, 6 months, 1 year and 2 years post-op	No
Other	Patient-reported outcome using the KOOS assessment		6 weeks, 6 months, 1 year and 2 years post-op	No
Other	Patient-reported outcome using the HAAS assessment		6 weeks, 6 months, 1 year and 2 years post-op	No
Other	Patient-reported outcome using the Kujala score		6 weeks, 6 months, 1 year and 2 years post-op	No
Other	Patient-reported outcome using the Oxford Knee Score		6 weeks, 6 months, 1 year and 2 years post-op	No
Other	Patient-reported outcome using the EQ-5D assessment		6 weeks, 6 months, 1 year and 2 years post-op	No
Other	Radiographic assessment		6 weeks, 6 months, 1 year and 2 years post-op	No
Primary	Survivorship (revision)	Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)	2 years	Yes