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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT00698867
Eligibility Criteria:
Inclusion Criteria:
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Inflammatory arthritis
* Revision where other devices or treatments have failed
* Correction of functional deformity
* Treatment of acute fractures or non-union about the elbow
Patient Selection factors to be considered include:
* Need to obtain pain relief and improve function.
* Ability and willingness to follow instructions including control of weight and activity levels.
* Patients who are able and willing to return for follow-up evaluations.
* Patients with a good nutritional state.
* Patients with full skeletal maturity.
* Patients of all races and gender.
* Patients who are able to follow care instructions.
Exclusion Criteria:
* Patients less than 18 years.
* Patients with marked bone loss which would preclude proper fixation of the prosthesis.
* Metabolic disorders, which may impair bone formation.
* Patients who are pregnant.
* Patients with an active or suspected infection in or around the elbow or distant foci of infections, which may spread to the implant site.
* Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
* Patients unwilling or unable to comply with a rehabilitation program for elbow replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00698867
Study Brief:
Protocol Section:
NCT00698867