Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02494544
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Brief Summary:

Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.

The patient will conduct functional testing and answer questionnaires.

The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.


Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Off the Shelf Total Knee Replacement Device: ConforMIS iTotal Knee Replacement Not Applicable

Detailed Description:
To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Site staff that is performing functional testing on subject is blinded to what implant the patient has.
Primary Purpose: Basic Science
Official Title: A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Actual Study Start Date : July 1, 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: ConforMIS iTotal Knee replacement
iTotal patient-specific knee replacement system
Device: ConforMIS iTotal Knee Replacement
A knee replacement performed with patient specific implant and surgical jigs.

Active Comparator: DePuy total knee replacement
Off the shelf knee replacement system
Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker

Active Comparator: Zimmer total knee replacement
Off the shelf knee replacement system
Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker

Active Comparator: Biomet total knee replacement
Off the shelf knee replacement system
Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker

Active Comparator: Smith & Nephew total knee replacement
Off the shelf knee replacement system
Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker

Active Comparator: Stryker total knee replacement
Off the shelf knee replacement system
Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker




Primary Outcome Measures :
  1. Functional Testing [ Time Frame: 1 year ]
    Comparing the functional testing differences between iTotal and off the shelf


Secondary Outcome Measures :
  1. Patient reported outcome using questionnaires such as the KOOS and VAS [ Time Frame: 1 year ]
    Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes.

  2. Incidents of major procedure-related and device related complications (including revision rates) [ Time Frame: 1 year ]
    To compare revision rates between groups

  3. Post-operative limb alignment based using x-ray views [ Time Frame: 1 year ]
    To compare post-operative limb alignment between two groups



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • 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:

  • Subject will require a simultaneous bilateral procedure
  • Other lower extremity surgery within 1 year
  • Severe (> 15º) fixed valgus or varus deformity
  • Severe (> 15º) extension deficit
  • Severe instability due to advanced loss of osteochondral structure
  • Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified
  • Insufficient bone stock on the femoral or tibial surfaces
  • Contralateral knee replacement surgery within the past 6 months
  • 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 (defined as HbA1c >7 or surgeon discretion)
  • Immunocompromised
  • Other physical disability affecting the hips, spine, or contralateral knee that limits function
  • Disabling chronic pain with narcotic dependence
  • Compromised PCL or collateral ligament
  • Prior history of failed implant surgery of the joint to be treated, including Unicompartmental Knee Arthroplasty (UKA), or Bicompartmental Knee Arthroplasty (BKA)
  • Prior history of failed high tibial osteotomy (HTO)
  • Participation in another clinical study which would confound results
  • Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494544


Contacts
Layout table for location contacts
Contact: Marc Quartulli 781-345-9191 marc.quartulli@conformis.com
Contact: Shirley Mak-Parisi 781-345-9049 shirley.mak-parisi@conformis.com

Locations
Layout table for location information
United States, California
University of California in San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Jesal Parekh, PhD    858-210-8727    jeparekh@ucsd.edu   
Principal Investigator: Scott Ball, MD         
Sharp Healthcare Recruiting
San Diego, California, United States, 92123
Contact: Irma Ramirez    858-499-5026    irma.ramirez@sharp.com   
Principal Investigator: Richard Coutts, MD         
Sub-Investigator: Joseph Jankiewicz, MD         
United States, Colorado
Denver-Vail Orthopedics Recruiting
Parker, Colorado, United States, 80134
Contact: Derek R Johnson, MD    303-214-4500      
Contact: Amy Griddley    303.214.4500    acrafferty@msn.com   
Principal Investigator: Derek R Johnson, MD         
United States, Connecticut
Yale School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Mary O'Connor, MD    203-737-2843      
Contact: Caryl Coraluzzi, RN    203-737-5515      
Principal Investigator: Mary O'Connor, MD         
United States, Massachusetts
Tufts University Active, not recruiting
Boston, Massachusetts, United States, 02111
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Stacee Clawson, RN    573-882-2663    clawsons@health.missouri.edu   
Principal Investigator: Thomas J Aleto, MD         
Sub-Investigator: Keeney, MD         
Sub-Investigator: Aggarwal, MD         
United States, New York
OrthoNY Not yet recruiting
Albany, New York, United States, 12205
Contact: Frederick Fletcher, MD    518-489-2663      
Contact: Sara K Holland    (518) 489-2663    Sara.Holland@sphp.com   
Principal Investigator: Frederick Fletcher, MD         
United States, Ohio
The Lindner Center for Research and Education Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Sandra Foglesong, RN    513-585-1777    Sandra.Foglesong@thechristhospital.com   
Contact: Darlene Rock, RN    513-585-1777    darlene.rock@TheChristHospital.com   
Principal Investigator: Michael Swank, MD         
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Mary O'Connor, MD Yale School of Medicine

Layout table for additonal information
Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT02494544     History of Changes
Other Study ID Numbers: 12-005
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by ConforMIS, Inc.:
knee implant
knee replacement
total knee replacement

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases