Phase
Condition
Joint Injuries
Lupus
Arthritis And Arthritic Pain
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: i) Male or female subjects, aged between 18 and 65 years inclusive. ii) Subjects with current indications for standard MoM hip resurfacing arthroplastysuitable for cementless fixation in the acetabulum. These include pain, deformity, and lossof function, which are not responsive to medical treatment. iii) Subjects who are able to give voluntary, written informed consent to participate inthis investigation and from whom consent has been obtained. iv) Subjects, who, in the opinion of the Investigator, are able to understand thisinvestigation, co-operate with the investigational procedures and are willing to return tothe hospital for all the required post-operative follow-ups.
Exclusion
Exclusion Criteria: i) Subjects who, in the opinion of the Investigator, have an existing condition that wouldcompromise their participation and follow-up in this study. ii) Subjects with proven significant osteoporosis and poor bone quality. iii) Subjects with compromised renal function. iv) Subjects with proven metal sensitivity. v) Subjects with infectious, highly communicable diseases, which may limit follow-up i.e.Active tuberculosis, hepatitis, immuno-compromised conditions, etc. vi) Women who are pregnant. vii) Subjects who are known drug or alcohol abusers or with psychological disorders thatcould affect follow-up care or treatment outcomes. viii) Subjects who have participated in a clinical study with an investigational product inthe last 6 month(s). ix) Subjects who are currently, or have been in the last 12 months, participating in aclinical study which involves exposure to ionising radiation. x) Subjects who are currently involved in any injury litigation claims. Additional Exclusion Criteria for Subjects Undergoing Blood Analysis
Subjects who currently have other metallic foreign bodies including trauma productsand joint arthroplasties unless known to be pure titanium, titanium alloy.
Subjects who, in the opinion of the investigator, will possibly require a separatejoint replacement operation within the next two years, including revision operations
Study Design
Connect with a study center
St Augustine's Hospital
Durban,
South AfricaSite Not Available

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