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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00351793
Eligibility Criteria:
Inclusion Criteria:
* A combined deformity of \<30 degrees = group 1
* A combined deformity of \>30 degrees = group 2
* Patient is willing to consent to participate in the study
* Patient is available for follow-up through at least 2 years but preferably 5 years
* Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk
* Patients who are fluent in English and are able to understand their role in a clinical trial
Exclusion Criteria:
* Active, local infection or systemic infection
* Fibromyalgia patients
* Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00351793
Study Brief:
Protocol Section:
NCT00351793