Informed Consent | Protocol Compliance
Item
able and willing to give informed consent and to comply with the study protocol and follow-up instructions.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Knee Osteoarthritis Symptomatic | Symptoms Bilateral | Knee More Symptomatic Involved
Item
symptomatic oa of the knee, as defined by the american college of rheumatology's clinical criteria for classification and reporting of oa of the knee. if symptoms are bilateral, then the knee identified by the subject as more symptomatic will serve as the index knee.
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
C0022742 (UMLS CUI [3,1])
C0205172 (UMLS CUI [3,2])
C0231220 (UMLS CUI [3,3])
C1314939 (UMLS CUI [3,4])
Pain of knee observed on ambulation WOMAC scale | Pain walking on the flat
Item
ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the womac.
boolean
C2090050 (UMLS CUI [1,1])
C3472647 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0560053 (UMLS CUI [2,2])
Knee Osteoarthritis Radiography Kellgren-Lawrence score
Item
radiographic oa of the study knee of grade 2 or 3, as defined by the modified kellgren and lawrence (k-l) grading scale.
boolean
C0409959 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
Osteoarthritis Medial compartment of knee | Narrowed joint space Qualitative | Bone Cyst Medial | Sclerosis | Osteophyte
Item
medial compartment oa, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte.
boolean
C0029408 (UMLS CUI [1,1])
C0447799 (UMLS CUI [1,2])
C1859695 (UMLS CUI [2,1])
C0205556 (UMLS CUI [2,2])
C0005937 (UMLS CUI [3,1])
C0205098 (UMLS CUI [3,2])
C0036429 (UMLS CUI [4])
C1956089 (UMLS CUI [5])
Wear appropriate shoes Clinical Trial Unable | Wear appropriate shoes Clinical Trial Unwilling
Item
inability or unwillingness to wear study shoes for at least 6 hours/day for 6 days/week
boolean
C2203003 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C2203003 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Flexion contracture of the knee Degree Quantity | Difficulty walking unassisted
Item
knee flexion contracture of > 15 degrees or inability to ambulate without assistance.
boolean
C0409355 (UMLS CUI [1,1])
C2348088 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2183457 (UMLS CUI [2])
Osteoarthritis of hip | Osteoarthritis of ankle | Pain Hip WOMAC scale | Pain Ankle WOMAC scale
Item
presence of clinically significant oa of the hip or ankle or pain greater than 20 mm at these sites (womac).
boolean
C0029410 (UMLS CUI [1])
C0409931 (UMLS CUI [2])
C0030193 (UMLS CUI [3,1])
C0019552 (UMLS CUI [3,2])
C3472647 (UMLS CUI [3,3])
C0030193 (UMLS CUI [4,1])
C0003086 (UMLS CUI [4,2])
C3472647 (UMLS CUI [4,3])
Valgus deformity Knee Degree Quantity | Varus angulation Knee Degree Quantity
Item
> 3 degrees valgus or >12 degrees varus deformity of either knee, defined by the mechanical axis (hip-knee angle).
boolean
C0042282 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C2348088 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0432593 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C2348088 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Osteoarthritis Lateral compartment of knee Predominant | Narrowed joint space Lateral Knee Involved | Narrowed joint space Medial Knee Involved | Narrowed joint space Lateral Knee Contralateral | Narrowed joint space Medial Knee Contralateral
Item
predominant lateral compartment oa, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either the index or the contralateral knee.
boolean
C0029408 (UMLS CUI [1,1])
C0447800 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C1859695 (UMLS CUI [2,1])
C0205093 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C1314939 (UMLS CUI [2,4])
C1859695 (UMLS CUI [3,1])
C0205098 (UMLS CUI [3,2])
C0022742 (UMLS CUI [3,3])
C1314939 (UMLS CUI [3,4])
C1859695 (UMLS CUI [4,1])
C0205093 (UMLS CUI [4,2])
C0022742 (UMLS CUI [4,3])
C0441988 (UMLS CUI [4,4])
C1859695 (UMLS CUI [5,1])
C0205098 (UMLS CUI [5,2])
C0022742 (UMLS CUI [5,3])
C0441988 (UMLS CUI [5,4])
Arthritis Systemic
Item
concurrent systemic inflammatory arthropathy,
boolean
C0003864 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Knee Arthroplasty | Repair of hip | Arthroscopy, knee, surgical | Fracture of lower limb
Item
prior knee or hip arthroplasty, or surgical arthroscopy of either knee within previous 3 months or history of fracture of either lower extremity within 6 months of study entry.
boolean
C0086511 (UMLS CUI [1])
C0186193 (UMLS CUI [2])
C3701616 (UMLS CUI [3])
C0810370 (UMLS CUI [4])
Foot Disease Intrinsic | Hallux Rigidus | Hallux Valgus | Metatarsalgia | Fasciitis, Plantar | Peripheral Neuropathy | Condition affecting the foot Exacerbated Footwear
Item
intrinsic foot disease including hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated by particular footwear.
boolean
C0016510 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
C0264134 (UMLS CUI [2])
C0018536 (UMLS CUI [3])
C0025587 (UMLS CUI [4])
C0149756 (UMLS CUI [5])
C0031117 (UMLS CUI [6])
C4061112 (UMLS CUI [7,1])
C1444749 (UMLS CUI [7,2])
C0336894 (UMLS CUI [7,3])
Intra-Articular Injection Knee Involved | Steroids | Hyaluronan Derivative
Item
intra-articular injection in the index knee: steroids within 6 weeks, hyaluronan derivatives within 4 months.
boolean
C0021488 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
C0020196 (UMLS CUI [3,1])
C1527240 (UMLS CUI [3,2])
Pregnancy
Item
pregnant subjects will be excluded because of the x-rays required.
boolean
C0032961 (UMLS CUI [1])
Medical condition Completion of clinical trial Unable
Item
any medical condition that, in the opinion of the pi, would render the subject unable to complete the study.
boolean
C3843040 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])