Post-Market Study of the EPIK Knee System

Osteoarthritis Clinical Trial

— EPIK  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01464632
• Other study ID #: PS-707
• Status: Withdrawn
• Phase: N/A
• First received: November 2, 2011
• Last updated: May 14, 2012
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis
• Post Traumatic Degenerative Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Hill Country Sports Medicine	Kyle	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes