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

NCT01529099 | Completed Phase 4

• 1 other identifier: CT10/01
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 3

Brief Summary

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

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.

Outcome Measures

Primary Outcomes (1)

• Survivorship (revision)

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

  2 years

Other Outcomes (8)

• 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

Study Arms (1)

Sigma HP Partial Knee

EXPERIMENTAL

Partial knee replacement

Device: SIGMA HP PARTIAL KNEE

Interventions

SIGMA HP PARTIAL KNEE DEVICE

SIGMA HP PARTIAL KNEE

Also known as: 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

Sigma HP Partial Knee

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• DePuy International: lead

Study Sites (3)

Orthopedic Institute IRCCS Galeazzi

Milan, Italy

Location

CDC, Citta di Palma

Parma, Italy

Location

Schulthess Klinik

Zurich, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis; Gout; Chondrocalcinosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: February 8, 2012
• Study Start: January 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 30, 2016

Record last verified: 2015-06

Locations

CH (1); IT (2)