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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT04002518
Eligibility Criteria:
Inclusion Criteria:
* Patient must be 18 years of age or older.
All patients operated on for the following indications:
* Group 1, Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
2. Arthrodesis of the foot, wrist and elbow.
3. Small and long bone osteotomies.
4. Fracture fixation of small bones, small bone fragments and long bones.
* Group 2, Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
1. Fixation of fractures in long bones and long bone fragments.
2. Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
3. Arthrodesis and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
* Group 3, Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
1. Slipped capital femoral epiphysis
2. Pediatric femoral neck fractures
3. Tibial plateau fractures
4. SI joint disruptions
5. Intercondylar femur fractures
6. Subtalar arthrodesis
7. Fixation of pelvis and iliosacral joint
* Patients must have the ability and willingness to follow instructions, including control of weight and activity levels.
* Patient must have a good nutritional state.
Exclusion Criteria:
* Infections.
* Patient conditions including blood supply limitations, insufficient quantity or quality of bone.
* Patients with mental or neurologic conditions who are unwilling or incapable fo following postoperative care instructions.
* Foreign body sensitivity where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Patient is known to be pregnant or breastfeeding.
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04002518
Study Brief:
Protocol Section:
NCT04002518