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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT03721835
Eligibility Criteria:
Inclusion Criteria:
1. Must be 18 years of age or older
2. Must provide written informed consent
3. Willing to make all required study visits for one year post-operation
4. Subject has experienced a displaced or non-displaced intracapsular femoral neck fracture and is scheduled for repair using the CONQUEST FN Femoral Neck Fracture System.
Exclusion Criteria:
1. Subject with known sensitivity or allergies to stainless steel
2. Subject with fracture occurring more than 7 days prior to surgery
3. Subject has more than one fracture on the hip requiring surgery
4. Subject is considered obese by a Body Mass Index \> 40 at the time of surgery
5. Therapy with another investigational agent within thirty 30 days of screening
6. Subject has emotional or neurological condition that precludes cooperation and compliance
7. Subject has undergone previous surgery on hip.
8. Subject has severe bow of the target hip or gross distortion of the femur.
9. Current systemic therapy with cytotoxic drugs
10. Subject has a physical condition that would preclude adequate implant support or impede healing (e.g. blood supply impairment, insufficient bone quality or quantity, or an active local or systemic infection).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03721835
Study Brief:
Protocol Section:
NCT03721835