Post-Market Study of the EPIK Knee System

This study has been withdrawn prior to enrollment.
(Unable to enroll any study participants.)
Sponsor:
Information provided by (Responsible Party):
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT01464632
First received: November 2, 2011
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Osteoarthritis
Post Traumatic Degenerative Disease
Device: EPIK™ uni-compartmental knee

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Open Label Study of the Short-and Midterm Safety and Efficacy of the EPIK Uni-Compartmental Knee System in Community Practice

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • Revision Rate Post Surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement.


Secondary Outcome Measures:
  • Revision rate post surgery [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement.


Enrollment: 0
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: EPIK

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464632

Locations
United States, Texas
Hill Country Sports Medicine
Kyle, Texas, United States, 78640
Sponsors and Collaborators
Encore Medical, L.P.
Investigators
Principal Investigator: Christina M Sheely, D.O. Hill Country Sports Medicine
  More Information

No publications provided

Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT01464632     History of Changes
Other Study ID Numbers: PS-707
Study First Received: November 2, 2011
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Encore Medical, L.P.:
medial knee replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014