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:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT00822159
Eligibility Criteria:
Inclusion Criteria:
* Patients 50 years or older
* Patients with trochanteric or femoral neck fractures, classified as: AO 31-A1, AO 31-A2, AO 31-A3, AO 31-B1, AO 31-B2, AO 31-B3
* Patients undergoing fixation with DHS (135° aiming device, anti-rotational K-wire)
* Patients willing to participate in the study according to the clinical investigation plan
* Patients able to understand and read country national language at an elementary level
* Signed written informed consent by the patient or legal guardian
Exclusion Criteria:
* Bilateral hip fractures (at present or in the past)
* Open hip fracture
* Any previous surgical procedures of the hip (ipsilateral / contralateral)
* More than 7 days between injury and surgery
* Polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening)
* Patients being pregnant or breast-feeding
* Pathologic fractures
* Active malignancy
* Psychiatric disorders that would preclude reliable assessment (e.g. severe depression)
* Drug or alcohol abuse
* Patients having participated in any other device or drug related clinical trial within the previous month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00822159
Study Brief:
Protocol Section:
NCT00822159