Age
Item
patient 18-75 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain | Rheumatoid arthritis | Osteoarthritis | Traumatic arthritis | Polyarthritis | Collagen disorders | Avascular necrosis of the femoral condyle | Post-traumatic loss of joint configuration | Valgus deformities | Varus deformities | Flexion deformities | Failure of previous surgical attempt that did not include a knee arthroplasty
Item
patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
boolean
C0086511 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0231749 (UMLS CUI [1,4])
C0205082 (UMLS CUI [1,5])
C0003873 (UMLS CUI [2])
C0029408 (UMLS CUI [3])
C0152086 (UMLS CUI [4])
C0162323 (UMLS CUI [5])
C0009326 (UMLS CUI [6])
C0027543 (UMLS CUI [7,1])
C0582800 (UMLS CUI [7,2])
C0022745 (UMLS CUI [8,1])
C0302142 (UMLS CUI [8,2])
C0231288 (UMLS CUI [8,3])
C0432593 (UMLS CUI [9])
C0042282 (UMLS CUI [10])
C0302142 (UMLS CUI [11,1])
C0231452 (UMLS CUI [11,2])
C0543467 (UMLS CUI [12,1])
C0205156 (UMLS CUI [12,2])
C0231175 (UMLS CUI [12,3])
C0086511 (UMLS CUI [12,4])
C0332197 (UMLS CUI [12,5])
Informed consent
Item
patient has participated in a study-related informed consent process
boolean
C0021430 (UMLS CUI [1])
Informed consent
Item
patient is willing and able to provide written informed consent by signing and dating the irb or ec approved informed consent form
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
patient is willing and able to complete scheduled study procedures and follow-up evaluations
boolean
C0525058 (UMLS CUI [1])
Patient is a candidate for commercially available Persona fixed bearing knee components
Item
independent of study participation, patient is a candidate for commercially available persona fixed bearing knee components implanted in accordance with product labeling
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0021102 (UMLS CUI [1,4])
C0680536 (UMLS CUI [1,5])
Participating in any other surgical intervention studies or pain management studies
Item
patient is currently participating in any other surgical intervention studies or pain management studies
boolean
C2348568 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0002766 (UMLS CUI [2,2])
History of infection in the affected joint | Other local infection | Other systemic infection
Item
previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
boolean
C0009450 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Insufficient bone stock on femoral or tibial surfaces
Item
insufficient bone stock on femoral or tibial surfaces
boolean
C0262950 (UMLS CUI [1,1])
C0015811 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0262950 (UMLS CUI [2,1])
C0040184 (UMLS CUI [2,2])
C0231180 (UMLS CUI [2,3])
Skeletal immaturity
Item
skeletal immaturity
boolean
C3825673 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Neurogenic arthropathy
Item
neuropathic arthropathy
boolean
C0003892 (UMLS CUI [1])
Osteoporosis | A loss of musculature | Neuromuscular disease that compromises the affected limb
Item
osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
boolean
C0029456 (UMLS CUI [1])
C0026846 (UMLS CUI [2])
C0027868 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0449685 (UMLS CUI [3,3])
Stable, painless arthrodesis in a satisfactory functional position
Item
stable, painless arthrodesis in a satisfactory functional position
boolean
C0003881 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0234225 (UMLS CUI [1,3])
C0733755 (UMLS CUI [1,4])
Instability due to the absence of collateral ligament integrity
Item
severe instability secondary to the absence of collateral ligament integrity
boolean
C0022410 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0206365 (UMLS CUI [1,3])
Rheumatoid arthritis accompanied by an ulcer of the skin | RA with a history of recurrent breakdown of the skin
Item
rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
boolean
C0003873 (UMLS CUI [1,1])
C0037299 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0150077 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])
C0262926 (UMLS CUI [2,4])
Hypersensitivity to the implant materials | Hypersensitivity to the implant materials suspected
Item
patient has a known or suspected sensitivity or allergy to one or more of the implant materials
boolean
C0020517 (UMLS CUI [1,1])
C0440216 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0440216 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Pregnancy | Vulnerable Populations
Item
patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
boolean
C0032961 (UMLS CUI [1])
C0949366 (UMLS CUI [2])
Partial knee arthroplasty for the ipsilateral knee | Total knee arthroplasty for the ipsilateral knee
Item
patient has previously received partial or total knee arthroplasty for the ipsilateral knee
boolean
C0086511 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0864243 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])