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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT02788994
Eligibility Criteria:
Inclusion Criteria:
* Age 55-95 years
* Fresh unstable (AO/OTA type A2) pertrochanteric fracture
* If medically fit, patient will undergo surgical fixation within 48 hours of admission. Otherwise, all patients to be recruited must undergo surgery within 7 days of admission
* Patient or patient's carer/personal or nominated consultee has provided informed consent/assent to participate in the study
* Patient is considered able to complete the study assessment and visit schedule in the opinion of the investigating team
Exclusion Criteria:
* Unable to ambulate pre-injury, even with walking aids
* Unable to undergo surgical fixation within 7 days of admission
* Patient is for any reason considered unable to carry out the required study assessments or complete the follow-up visit schedule, in the opinion of the investigating team
* Previous stroke (non-recovered)
* Recent myocardial infarction (up to 60 days)
* Presence of fracture(s) in contralateral leg
* Presence of fracture(s) in ipsilateral leg, in addition to the pertrochanteric hip fracture
* Known renal or hepatic failure as defined by:
* Elevated transaminases ≥ 2.0 x upper limits of normal for:
* Serum aspartate aminotransferase (AST)
* Serum alanine aminotransferase (ALT)
* Significantly impaired renal function as determined by a derived creatinine clearance of ≤ 30 mL/min using the Modification of Diet in Renal Disease equation21
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
95 Years
Study:
NCT02788994
Study Brief:
Protocol Section:
NCT02788994