Trial record 6 of 237 for:    Open Studies | knee replacement

A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

This study is currently recruiting participants.
Verified January 2014 by ConforMIS, Inc.
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.
ClinicalTrials.gov Identifier:
NCT01820650
First received: March 26, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.


Condition Intervention
Osteoarthritis of the Knee
Device: iTotal G2 CR Knee Replacement System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

Resource links provided by NLM:


Further study details as provided by ConforMIS, Inc.:

Primary Outcome Measures:
  • 2011 Knee Society Score [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2013
Estimated Study Completion Date: March 2025
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: iTotal G2 CR Knee Replacement System
    Total Knee replacement
Detailed Description:

If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with osteoarthritis of the knee

Criteria

Inclusion Criteria:

  • Clinical condition included in the approved Indications For Use for the iTotal® CR
  • Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
  • Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
  • > 18 years of age

Exclusion Criteria:

  • Simultaneous bilateral procedure required
  • BMI > 40
  • Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
  • Poorly Controlled diabetes
  • Neuromuscular conditions which prevent patient from participating in study activities
  • Active local or systemic infection
  • Immunocompromised
  • Fibromyalgia or other general body pain related condition
  • Rheumatoid arthritis or other forms of inflammatory joint disease
  • Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
  • Diagnosed with or receiving treatment for Osteoporosis
  • Other physical disability affecting the hips, spine, or contralateral knee.
  • Severe instability due to advanced loss of osteochondral structure
  • Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
  • Compromised PCL or collateral ligament
  • Severe fixed valgus or varus deformity of >15º
  • Extensor lag > 15 º
  • Fixed flexion contracture ≥ 15 º
  • Unwilling or unable to comply with study requirements
  • Participation in another clinical study which would confound results
  • Allergy to any of the implant materials
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820650

Locations
United States, Florida
JFK Medical Center Recruiting
Atlantis, Florida, United States, 33462
Contact: Jamie Kosik    561-548-1414    Jamie.Kosik@hcahealthcare.com   
Principal Investigator: Gregory Martin, MD         
United States, Nevada
Orthopaedic Instatute of Henderson Recruiting
Henderson, Nevada, United States, 89052
Contact: Chris Johnston    702-565-6565 ext 312    cJohnston@oihnv.com   
Principal Investigator: Robert Tait, MD         
United States, Tennessee
Tennessee Orthopaedic Alliance Recruiting
Nashville, Tennessee, United States, 37203
Contact: Katie Vanhooser, PA    615-329-6600    vanhooserkj@toa.com   
Principal Investigator: William Kurtz, MD         
United States, Texas
Joint Replacement Associates Recruiting
Houston, Texas, United States, 77030
Contact: Terry Clyburn, MD    713-357-4752      
United States, Vermont
Mansfield Orthopaedics Recruiting
Morrisville, Vermont, United States, 05661
Contact: Leah Moris, MS, PA-C    802-888-8405    lemorse@chsi.org   
Principal Investigator: Bryan Huber, MD         
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
Study Director: Marc Quartulli ConforMIS, Inc.
Principal Investigator: Terry Clyburn, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01820650     History of Changes
Other Study ID Numbers: CCP 12-001
Study First Received: March 26, 2013
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ConforMIS, Inc.:
osteoarthritis
knee replacement
patient-specific

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

ClinicalTrials.gov processed this record on April 17, 2014