Age
Item
i) male or female subjects, aged between 18 and 65 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Indication Hip resurfacing arthroplasty | Acetabular component fixation Bone Cement Lack | Pain Unresponsive to Treatment | Deformity Unresponsive to Treatment | Function Loss Unresponsive to Treatment
Item
ii) subjects with current indications for standard metal-on-metal (mom) hip resurfacing arthroplasty suitable for cementless fixation in the acetabulum. these include pain, deformity, and loss of function, which are not responsive to medical treatment.
boolean
C3146298 (UMLS CUI [1,1])
C1719287 (UMLS CUI [1,2])
C0449349 (UMLS CUI [2,1])
C0005934 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0030193 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0302142 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C0031843 (UMLS CUI [5,1])
C1517945 (UMLS CUI [5,2])
C0205269 (UMLS CUI [5,3])
Informed Consent
Item
iii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance | Postoperative follow-up visit Compliance behavior
Item
iv) subjects, who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the hospital for all the required post-operative follow-ups.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C2585426 (UMLS CUI [3,1])
C1321605 (UMLS CUI [3,2])
Condition Affecting Study Subject Participation Status | Condition Affecting Clinical Study Follow-up
Item
i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Osteoporosis Significant | Bone Quality Poor
Item
ii) subjects with proven significant osteoporosis and poor bone quality.
boolean
C0029456 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0262950 (UMLS CUI [2,1])
C0332306 (UMLS CUI [2,2])
C0542537 (UMLS CUI [2,3])
Renal Insufficiency
Item
iii) subjects with compromised renal function.
boolean
C1565489 (UMLS CUI [1])
Metal allergy
Item
iv) subjects with proven metal sensitivity.
boolean
C0577627 (UMLS CUI [1])
Highly Communicable Diseases | Clinical Study Follow-up Limited | Tuberculosis | Hepatitis | Immune system Impaired
Item
v) subjects with infectious, highly communicable diseases, which may limit follow-up i.e. active tuberculosis, hepatitis, immuno-compromised conditions, etc.
boolean
C0009450 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0041296 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
C0020962 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
Pregnancy
Item
vi) women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Substance Use Disorders | Mental disorders Affecting Follow-Up Care | Mental disorders Affecting Treatment outcome
Item
vii) subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C3899107 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0085415 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs
Item
viii) subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Study Subject Participation Status | Involvement Exposure to Ionizing radiation
Item
ix) subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.
boolean
C2348568 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0034538 (UMLS CUI [2,3])
Litigation Involvement with
Item
x) subjects who are currently involved in any injury litigation claims.
boolean
C0079706 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])