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

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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.

Study Description
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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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Device: Conformis iTotal Identity Knee Replacement System

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study to Evaluate the Conformis iTotal Identity Knee Replacement System
Actual Study Start Date : October 12, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Revision rate [ Time Frame: Post implantation up to 10 years ]
  2. Incidence of major procedure-related and device-related complications, including infection rate [ Time Frame: Post implantation up to 10 years ]
  3. 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 ]
  4. 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

  5. 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) ]
  6. Length of hospital stay in hours [ Time Frame: Time from patient admission to hospital before surgery til discharge from hospital (up to 72 hours) ]
  7. 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) ]
  8. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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)
Contacts and Locations
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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): NCT04667559


Contacts
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Contact: Marc Quartulli 7813459191 marc.quartulli@conformis.com

Locations
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United States, Florida
Personalized Orthopedic Research Institute Not yet recruiting
Boynton Beach, Florida, United States, 33437
Contact: Brenda Sapir    561-733-5888 ext 110    brendas@popb.md   
Principal Investigator: Gregory Martin, MD         
United States, Tennessee
Tennessee Orthopaedic Alliance Recruiting
Nashville, Tennessee, United States, 37203
Contact: Rena Rolfe    615-719-2922    renacrolfe@gmail.com   
Principal Investigator: William Kurtz, MD         
Sponsors and Collaborators
ConforMIS, Inc.
More Information
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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT04667559    
Other Study ID Numbers: 20-001
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases