A Study to Evaluate the Conformis iTotal Identity Knee Replacement System

Terminated

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT04667559
• Lead Sponsor: Restor3D

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 available

Study Timeline

• Study Start: 2020-10-12
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-14
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain and function	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

Name	Time	Method
Incidence of major procedure-related and device-related complications, including infection rate	Post implantation up to 10 years
Revision rate	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)
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
Length of hospital stay in hours	Time from patient admission to hospital before surgery til discharge from hospital (up to 72 hours)
blood loss during surgery	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	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)
Number of patients demonstrating radiographic loosening, radiolucency	Post implantation up to 10 years	Review of x-rays to subjectively determine evidence of implant disassociation with bone

Trial Locations

Locations (2)

Tennessee Orthopaedic Alliance; 🇺🇸 Nashville, Tennessee, United States

Personalized Orthopedic Research Institute; 🇺🇸 Boynton Beach, Florida, United States