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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01106560
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 18-75 years at time of surgery.
* Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip.
* Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
* Patients who signed the study consent form prior to surgery.
Exclusion Criteria:
* Pregnant women or women who plan to conceive in the future.
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
* Those already treated by with a Total Hip Replacement (THR) (i.e. requiring a revision hip replacement).
* Those with co-existent ipsilateral knee disease or back problems
* Muscle contracture around the hip joint
* Individuals who have undergone organ transplant.
* Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
* Individuals who have had a THR on the contra-lateral side within the 6 months.
* Individuals who have undergone a THR on the contralateral side and whose outcome is considered unsatisfactory or not good. An unsatisfactory or poor result is defined as achieving a total UCLA score (including activity) \< 16 points.
* Individuals requiring bilateral hip replacement.
* Individuals whose body mass index (BMI; kg/m2) \>35.
* Individuals with active or suspected infection or sepsis.
* Individuals with renal failure and/or renal insufficiency.
* Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01106560
Study Brief:
Protocol Section:
NCT01106560