Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT04667559
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)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04667559
Study Brief:
Protocol Section:
NCT04667559