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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT02029469
Eligibility Criteria:
Inclusion Criteria:
* The following patient will be included in the study - Patient who:
* Is treated with the Ascension HRA;
* Is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis;
* Has mild or moderate humeral head deformity and /or limited motion;
* Has post-traumatic arthritis;
* Has an intact or reparable rotator cuff;
* Has the means and ability to return for all required study visits
* Is willing to participate in the study;
* Has signed an Informed Consent Form;
* Is at least 18 years of age and skeletally mature at the time of surgery;
* Is less than 75 years of age at the time of surgery
Exclusion Criteria:
The following patients will be excluded from the study - Patients who:
* Infection, sepsis, and osteomyelitis;
* Osteoporosis;
* Metabolic disorders which may impair bone formation;
* Osteomalacia;
* Rapid joint destruction, marked bone loss or bone resorption apparent on X-ray;
* Revision procedures where other devices or treatments have failed
* Refuses to be in the study; or does not have the means and ability to return for all required study visits;
* Currently participating in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02029469
Study Brief:
Protocol Section:
NCT02029469