Post-Market Study of the EPIK Knee System

NCT01464632 | Withdrawn

• 1 other identifier: PS-707
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis; Post Traumatic Degenerative Disease

Keywords

medial knee replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Revision rate post surgery

  2 year

Study Arms (1)

Primary

Post Market Study

Device: EPIK™ uni-compartmental knee

Interventions

EPIK™ uni-compartmental knee DEVICE

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.

Also known as: EPIK

Primary

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Encore Medical, L.P.: lead

Study Sites (1)

Hill Country Sports Medicine

Kyle, Texas, 78640, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Christina M Sheely, D.O.

  Hill Country Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 3, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

US (1)