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 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT04287257
Eligibility Criteria:
Inclusion Criteria:
1. Subjects with closed unilateral dorsally angulated fracture of the distal radius (Colles') visible by x-ray.
2. Subjects treated conservatively by immobilization ± closed reduction
3. Age \>18 years
4. Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Exclusion Criteria:
1. Subjects with intra articular fracture or extra-articular fracture that meets the criteria for operative fracture fixation.
2. Subjects with pins or plates in the wrist
3. Sustained previous fractures or bone surgery in the currently fractured distal forearm
4. Synovial pseudarthrosis
5. Subjects with multiple trauma (several fractures at once)
6. Subjects suffering from joint diseases that affect the function of the wrist and/or hand of the injured arm.
7. Pregnancy
8. Women who are breast-feeding.
9. Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
10. presence of a life supporting implanted electronical device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04287257
Study Brief:
Protocol Section:
NCT04287257