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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.
ClinicalTrials.gov Identifier:
NCT01820650
First received: March 26, 2013
Last updated: May 12, 2016
Last verified: May 2016
  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 ]

Enrollment: 359
Study Start Date: February 2013
Estimated Study Completion Date: March 2026
Estimated Primary Completion Date: March 2017 (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   (Adult, Senior)
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
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: NCT01820650

Locations
United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
United States, Maine
EMMC - Orthopaedic Surgery of Maine
Bangor, Maine, United States, 04401
United States, Michigan
Great Lakes Bone and Joint
Battle Creek, Michigan, United States, 49015
United States, Nevada
Orthopaedic Instatute of Henderson
Henderson, Nevada, United States, 89052
Desert Orthopedic Center
Las Vegas, Nevada, United States, 89121
United States, Tennessee
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States, 37203
United States, Texas
Advanced Orthopedics and Sports Medicine
Cypress, Texas, United States, 77429
Joint Replacement Associates
Houston, Texas, United States, 77030
United States, Vermont
Mansfield Orthopaedics
Morrisville, Vermont, United States, 05661
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

Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01820650     History of Changes
Other Study ID Numbers: 12-001 
Study First Received: March 26, 2013
Last Updated: May 12, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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 September 28, 2016