Clinical trial NCT04667559: A Study to Evaluate the Conformis iTotal Identity Knee Replacement System
Official title: A Prospective, Multicenter Study to Evaluate the Conformis iTotal Identity Knee Replacement System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis, Knee
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility 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)

Primary outcomes:
measure: Pain and function
timeFrame: 2 years post implantation
Secondary outcomes:
measure: Revision rate
timeFrame: Post implantation up to 10 years
measure: Incidence of major procedure-related and device-related complications, including infection rate
timeFrame: Post implantation up to 10 years
measure: 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
timeFrame: Post implantation up to 10 years
measure: Number of patients demonstrating radiographic loosening, radiolucency
timeFrame: Post implantation up to 10 years
measure: Length of procedure
timeFrame: 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)
measure: Length of hospital stay in hours
timeFrame: Time from patient admission to hospital before surgery til discharge from hospital (up to 72 hours)
measure: blood loss during surgery
timeFrame: 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)
measure: blood transfusion rates
timeFrame: 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)
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Personalized Orthopedic Research Institute
state: Florida
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
Study officials:
References: