A Study to Evaluate the Conformis iTotal Identity Knee Replacement System

Stopped early

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT04667559

Run by

Restor3D

People needed

22

Starts

2020-10-12

Expected to finish

2022-12-14

Last updated by the study team

2023-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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)

Where it is running

• Personalized Orthopedic Research Institute — Boynton Beach, Florida, United States
• Tennessee Orthopaedic Alliance — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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