A Study to Evaluate the Conformis iTotal Identity Knee Replacement System

NCT04667559 | Terminated FDA Device

• 1 other identifier: 20-001
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Pain and function

  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)

  2 years post implantation

Secondary Outcomes (8)

• Revision rate

  Post implantation up to 10 years

• Incidence of major procedure-related and device-related complications, including infection rate

  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

  Post implantation up to 10 years

• Number of patients demonstrating radiographic loosening, radiolucency

  Post implantation up to 10 years

• Length of procedure

  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)

Interventions

Conformis iTotal Identity Knee Replacement System DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Restor3D: lead

Study Sites (2)

Personalized Orthopedic Research Institute

Boynton Beach, Florida, 33437, United States

Location

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 14, 2020
• Study Start: October 12, 2020
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)