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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT00698750
Eligibility Criteria:
Inclusion Criteria:
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis
* Correction of functional deformity
* Reconstructable Rotator Cuff
* Treatment of acute fracture of the humeral head
* Traumatic arthritis
Exclusion Criteria:
* Patients less than 18 years.
* Patients with rapid joint destruction, osteomalacia, osteoporosis, or marked bone loss, which would preclude proper fixation of the prosthesis.
* Patients with marked bone loss apparent on roentgenogram.
* Metabolic disorders, which may impair bone formation.
* Patients who are pregnant.
* Patients with an active or suspected infection in or around the shoulder or distant foci of infections, which may spread to the implant site.
* Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue, which would prelude stability of the prosthesis.
* Patients who have had revision procedures where other devices or treatments have failed.
* 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 a cemented or cementless partial or total shoulder replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
* Patients with previous shoulder surgery or conditions that may interfere with the partial or total shoulder replacement's survival or outcome.
* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
* Patients who have had a partial or total shoulder arthroplasty on the contralateral shoulder within the last year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00698750
Study Brief:
Protocol Section:
NCT00698750