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

Sponsor

DePuy International (Industry)

Overall Status

Completed

CT.gov ID

NCT01529099

Collaborator

(none)

Enrollment

Locations

Arm

77.9

Duration (Months)

21.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Post-traumatic Arthritis Gout Pseudo-gout	Device: SIGMA HP PARTIAL KNEE	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sigma HP Partial Knee Partial knee replacement	Device: SIGMA HP PARTIAL KNEE SIGMA HP PARTIAL KNEE Other 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

Arm

Intervention/Treatment

Experimental: Sigma HP Partial Knee

Partial knee replacement

Device: SIGMA HP PARTIAL KNEE

SIGMA HP PARTIAL KNEE

Other 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

Outcome Measures

Primary Outcome Measures

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

Other Outcome Measures

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]
Patient-reported outcome using the HAAS assessment [6 weeks, 6 months, 1 year and 2 years post-op]
Patient-reported outcome using the Kujala score [6 weeks, 6 months, 1 year and 2 years post-op]
Patient-reported outcome using the Oxford Knee Score [6 weeks, 6 months, 1 year and 2 years post-op]
Patient-reported outcome using the EQ-5D assessment [6 weeks, 6 months, 1 year and 2 years post-op]
Radiographic assessment [6 weeks, 6 months, 1 year and 2 years post-op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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.