Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by ConforMIS, Inc.
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.
ClinicalTrials.gov Identifier:
NCT01717001
First received: October 26, 2012
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.

ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: In Vivo Determination & Comparison of Knee Kinematics for Subjects Implanted With Either a Personalized ConforMIS or Traditional Knee Implant

Resource links provided by NLM:


Further study details as provided by ConforMIS, Inc.:

Primary Outcome Measures:
  • Patients with ConforMIS implant will experience more normal like kinematic pattern [ Time Frame: at least 6 months post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ConforMIS
Patients with ConforMIS implants
Standard Total Knee Implant
Patients implanted with standard total knee implant

Detailed Description:

Each subject will be asked to perform five activities in one continuous sequence: (1) stand up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep knee bend. Subjects will be video recorded from the waist down while performing the activities. The speed level of each trial will be based on the comfort level of the patient. The fluoroscopic images will be stored digitally for subsequent analysis on secure servers and workstations at the University of Tennessee.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are at least 6 month post-op with a ConforMIS knee replacement or a standard total knee replacement who meets the inclusion/exclusion criteria

Criteria

Inclusion Criteria:

  • At least 6 months post-op with no other surgical procedures conducted within the past 6 months
  • Between 40-70 years of age
  • Body weight of less than 250lbs
  • BMI of less than 38
  • Pregnant females will be excluded
  • TKA patients will be judged Clinically successful with an American Knee Society score of greater than 90
  • Must have 100 degrees post-op passive flexion with no ligamentous laxity or pain
  • Participants must be able to walk on level ground without aid of any kind and ascend/descend stairs without assistance.
  • All potential subjects will have either a personalized ConforMIS™ TKA or a traditional TKA manufactured by an orthopaedic company other than ConforMIS.
  • Patients from the physician's list who do not meet the study requirements will not be considered.
  • Patients must be willing to sign the Informed Consent and HIPAA forms to participate in the study.
  • Patients must be between 160cm (5'3) and 193cm (6'4) tall.
  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: NCT01717001

Contacts
Contact: Richard Komistek, PhD 865-974-2093 rkomiste@utk.edu
Contact: William Hamel, PhD 865-974-9376 whamel@utk.edu

Locations
United States, Tennessee
University of Tennessee Not yet recruiting
Knoxville, Tennessee, United States, 37996
Contact: Richard D Komistek, PhD    865-974-2093    rkomiste@utk.edu   
Principal Investigator: Richard D Komistek, PhD         
Sub-Investigator: William R Hamel, PhD         
Sub-Investigator: Adrija Sharma, PhD         
Tennessee Orthopedic Alliance Recruiting
Nashville, Tennessee, United States, 37203
Contact: William B Kurtz, MD    865-974-2093    kurtzwb@toa.com   
Principal Investigator: William B Kurtz, MD         
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
Principal Investigator: Richard D Komistek, PhD Univeristy of Tennessee
Principal Investigator: William Kurtz, MD Tennessee Orthopedic Alliance
  More Information

No publications provided

Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01717001     History of Changes
Other Study ID Numbers: Komistek 1
Study First Received: October 26, 2012
Last Updated: August 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ConforMIS, Inc.:
kinematics
knee joint

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

ClinicalTrials.gov processed this record on August 28, 2014