Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Prospective, Multicenter Study to Evaluate the Conformis iTotal Identity Knee Replacement System

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: NCT04667559
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Tracking Information
First Submitted Date November 9, 2020
First Posted Date December 14, 2020
Last Update Posted Date December 14, 2020
Actual Study Start Date October 12, 2020
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2020)
Pain and function [ Time Frame: 2 years post implantation ]
Measured by 2011 Knee Society Clinical Rating Score (objective knee score 0-125, function score 0-100, satisfaction score 0-40, expectation score 0-15 with higher scores meaning better outcome)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 8, 2020)
  • Revision rate [ Time Frame: Post implantation up to 10 years ]
  • Incidence of major procedure-related and device-related complications, including infection rate [ Time Frame: Post implantation up to 10 years ]
  • Post-operative hip-knee-ankle limb alignment (with 180 degrees being the expected outcome, plus or minus 5 degrees), if long leg x-rays available [ Time Frame: Post implantation up to 10 years ]
  • Number of patients demonstrating radiographic loosening, radiolucency [ Time Frame: Post implantation up to 10 years ]
    Review of x-rays to subjectively determine evidence of implant disassociation with bone
  • Length of procedure [ Time Frame: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours) ]
  • Length of hospital stay in hours [ Time Frame: Time from patient admission to hospital before surgery til discharge from hospital (up to 72 hours) ]
  • blood loss during surgery [ Time Frame: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours) ]
  • blood transfusion rates [ Time Frame: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective, Multicenter Study to Evaluate the Conformis iTotal Identity Knee Replacement System
Official Title A Study to Evaluate the Conformis iTotal Identity Knee Replacement System
Brief Summary This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with clinical condition indicated in the approved Instructions for Use for the Conformis iTotal Identity Knee Replacement System
Condition Osteoarthritis, Knee
Intervention Device: Conformis iTotal Identity Knee Replacement System
The iTotal® Identity KRS is a tri-compartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component.Using patient imaging, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 8, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2031
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical condition included in the approved Indications For Use for the iTotal Identity CR KRS
  • 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 with complete development of musculoskeletal structures

Exclusion Criteria:

  • Simultaneous bilateral procedure required
  • BMI > 40
  • Active malignancy (defined as a history of any invasive malignancy - except nonmelanoma skin cancer), unless subject 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 Investigator discretion)
  • Neuromuscular conditions which prevent subject from participating in study activities
  • Active local or systemic infection which precludes TKR procedure
  • Immunocompromised in the opinion of the Investigator
  • Medically diagnosed fibromyalgia or similar conditions that might impact the subject's ability to differentiate source of pain
  • 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 on, to an extent that the procedure is unjustified
  • Diagnosed with or receiving treatment for osteoporosis that is likely to confound results in the opinion of the Investigator
  • Other physical disability affecting the hips, spine, or contralateral knee that is likely to confound results in the opinion of the Investigator
  • 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 > 15º
  • Fixed flexion contracture ≥ 15º
  • Unwilling or unable to comply with study requirements
  • Participation in another clinical study which would confound results
  • Allergy to any of the implant materials
  • Pregnant or planning to become pregnant prior to study TKR procedure (in case of pregnancy after study TKR procedure, eligibility to continue with the protocol will be reviewed)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Marc Quartulli 7813459191 marc.quartulli@conformis.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04667559
Other Study ID Numbers 20-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ConforMIS, Inc.
Study Sponsor ConforMIS, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account ConforMIS, Inc.
Verification Date December 2020