Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00872794
Eligibility Criteria:
Inclusion Criteria:
i) Male or female subjects, aged between 18 and 65 years inclusive.
ii) Subjects with current indications for standard 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.
iii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
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.
Exclusion Criteria:
i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise 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 that could affect follow-up care or treatment outcomes.
viii) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
ix) Subjects who are currently, or have been in the last 12 months, participating in a clinical 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
1. Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium, titanium alloy.
2. Subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00872794
Study Brief:
Protocol Section:
NCT00872794