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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT02480868
Eligibility Criteria:
Inclusion Criteria:
1. The patient has signed the independent ethics committee approved informed consent form specific to this investigation prior to enrollment.
2. The patient is diagnosed with primary or secondary osteoarthritis requiring fusion of the ankle joint (tibiotalar) or the subtalar joint.
3. The fusion site should be able to be rigidly stabilized with two or three screws across the fusion site.
4. The patient is independent, ambulatory, and could comply with all post-operative evaluations and visits.
5. The patient is at least 18 years of age and considered to be skeletally mature.
Exclusion Criteria:
1. The patient has undergone previous fusion surgery of the proposed fusion site.
2. The fusion site requires other than screw fixation, more than three screws across the fusion site to achieve rigid fixation, or more than one kit (3 cc) of graft material.
3. There is radiographic evidence of bone cysts, segmental defects or growth plate fracture around the fusion site that may negatively impact bony fusion.
4. The patient currently has untreated malignant neoplasm(s) at the surgical site, or is currently undergoing radio- or chemotherapy.
5. The patient has severe diabetes with neuropathy.
6. The patient has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis or diabetes (e.g., renal osteodystrophy or hypercalcemia).
7. The patient uses chronic medications known to affect the skeleton (e.g., glucocorticoid usage \> 10 mg/day).
8. The patient uses immunosuppressive treatment or medication for osteoporosis.
9. The patient has systemic or severe local inflammation or infections.
10. The patient has a pre-fracture neuromuscular or musculoskeletal deficiency which might limit the ability to perform objective functional measurements.
11. The patient is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the investigator judges the patient to be unable or unlikely to remain compliant.
12. The patient has an allergy to reindeer protein.
13. The patient has received an investigational therapy or approved therapy for investigational use within 30 days of surgery.
14. The patient is a prisoner, known or suspected to be transient, or has a history of drug/alcohol abuse within the 12 months prior to screening for study entry.
15. The patient is pregnant or a female intending to become pregnant during the study period.
16. The patient is deemed morbidly obese (body mass index \[BMI\] \> 45 kg/m2).
17. The patient has a recent history of smoking during the past six months prior to screening for study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02480868
Study Brief:
Protocol Section:
NCT02480868