Nashville, Tennessee 37203

  • Osteoarthritis, Knee

Purpose:

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.


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)


NCT ID:

NCT04667559


Primary Contact:

Marc Quartulli
Phone: 7813459191
Email: marc.quartulli@conformis.com


Backup Contact:

N/A


Location Contact:

Nashville, Tennessee 37203
United States

Rena Rolfe
Phone: 615-719-2922
Email: renacrolfe@gmail.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 03, 2023

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