Post-Market Study of the EPIK Knee System (EPIK)

Prospective, Open Label Study of the Short-and Midterm Safety and Efficacy of the EPIK Uni-Compartmental Knee System in Community Practice

The purpose of this study is to determine the short-term (2 yr) and midterm (5 yr) cumulative revision rates of the EPIK™ Uni-compartmental Knee System.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis; Post Traumatic Degenerative Disease
• Intervention / Treatment: Device: EPIK™ uni-compartmental knee

Detailed Description

Medial uni-compartmental knee replacement (UKA) has been used for over 40 years to treat osteoarthritis (OA) of the knee. It is becoming more widely accepted as a treatment for early stage OA of the knee in order to preserve bony and ligamentous structures. The majority of the subjects who have received this knee are older (over 65 yrs) however, it is being used increasingly more frequently in younger individuals who have uni-compartmental knee disease so that bone may be spared in case the need arises in the future for a total knee arthroplasty. The study will take place at two sites within the United States and be managed by the Clinical Affairs Department at DJO Surgical in Austin, TX. The study will include only subjects who meet the indications for use criteria for the EPIK™ Uni-compartmental Knee System and who are candidates for UKA. Investigators will enroll up to 60 subjects at each of 2 sites within the United States, for a total of 100 subjects maximum.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Kyle, Texas, United States, 78640
      • Hill Country Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are between 18 years of age and 60 years of age at time of consent and have one side of the knee joint affected by compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures or deformity.

Description

Inclusion Criteria:

• Meet the indications for use of the EPIK Uni-compartmental knee system
• Must be a primary surgery
• Have a primary diagnosis of OA in the medial knee compartment
• Have active and passive flexion > 90º
• Have a fixed flexion contracture < 10º
• Have an intact ACL and PCL
• Be a primary, unilateral surgery
• Have BMI ≤ 35.00
• Must not have infection (or history of infection within last 3 months), chronic or acute, local or systemic
• Must not be pregnant
• Be willing and able to sign the informed consent
• Be willing to follow study procedures, including all follow up visits
• Be over 18 years of age (≥ 18) and 60 years or younger (≤ 60) at time of consent

Exclusion Criteria:

• Prior total or uni-knee arthroplasty (must be a primary surgery)
• Patello-femoral joint symptoms
• Bilateral surgical procedures
• BMI > 35.00
• Muscular, neurological or vascular deficiencies which compromise the affected extremity
• Insufficient bone quality which may affect the stability of the implant
• Infection (or history of infection within last 3 months), chronic or acute, local or systemic
• Is younger than 18 years of age (<18) or over 60 (>60) years of age
• Mental conditions that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements
• High levels of physical activity (ex. Competitive sports, heavy physical labor)
• Documented (active) alcohol or drug addictions
• Loss of ligamentous structures
• Prisoner
• Metals sensitivity
• Subject is pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary; Post Market Study	Device: EPIK™ uni-compartmental knee; This device is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or revision of previous arthroplasty.; Other Names: EPIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision Rate Post Surgery	To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision rate post surgery	To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement.	2 year

Collaborators and Investigators

• Sponsor: Encore Medical, L.P.
• Investigators: Principal Investigator: Christina M Sheely, D.O., Hill Country Sports Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 2, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 3, 2011

Study Record Updates

• Last Update Posted (Estimate): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: medial knee replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: PS-707