Age
Item
i) male or female subjects, aged between 18 and 70 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ii) 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
iii) 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])
Total Hip Replacement Primary | Indication Acetabular component fixation Bone Cement
Item
iv) subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.
boolean
C0040508 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0449349 (UMLS CUI [2,2])
C0005934 (UMLS CUI [2,3])
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])
Revision of hip replacement
Item
ii) subjects undergoing revision hip replacement.
boolean
C0186201 (UMLS CUI [1])
Pregnancy
Item
iii) women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Substance Use Disorders | Mental disorders Affecting Follow-Up Care | Mental disorders Affecting Treatment outcome
Item
iv) 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
v) subjects who have participated in a clinical study with an investigational product in the last 12 months.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Litigation Involvement with
Item
vi) subjects who are currently involved in any injury litigation claims.
boolean
C0079706 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Exclusion Criteria Hematologic Tests
Item
additional exclusion criteria for subjects having blood analysis:
boolean
C0680251 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Metallic foreign body | Trauma product | Arthroplasty | Titanium | Titanium Alloy
Item
1. subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
boolean
C1720389 (UMLS CUI [1])
C3714660 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C0003893 (UMLS CUI [3])
C0040302 (UMLS CUI [4])
C0040302 (UMLS CUI [5,1])
C0002154 (UMLS CUI [5,2])
Occupational Exposure Cobalt | Occupational Exposure Chromium
Item
2. subjects with an occupational exposure to cobalt or chromium.
boolean
C0028798 (UMLS CUI [1,1])
C0009148 (UMLS CUI [1,2])
C0028798 (UMLS CUI [2,1])
C0008574 (UMLS CUI [2,2])
Pharmaceutical Preparations Containing Cobalt | Pharmaceutical Preparations Containing Chromium | Vitamins Containing Cobalt | Vitamins Containing Chromium
Item
3. subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
boolean
C0013227 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0009148 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0008574 (UMLS CUI [2,3])
C0042890 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0009148 (UMLS CUI [3,3])
C0042890 (UMLS CUI [4,1])
C0332256 (UMLS CUI [4,2])
C0008574 (UMLS CUI [4,3])
Joint replacement Separate Patient need for | Surgical revision Patient need for
Item
4. subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
boolean
C0185317 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0558347 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Total Hip Replacement Bilateral
Item
5. subjects who are undergoing a simultaneous bilateral total hip replacement.
boolean
C0040508 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])