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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT01183260
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 - 85 years
* Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
* Stable Health: At the time of surgery based on physical examination and medical history.
* Patient is a revision total hip recipient, which requires a metal-backed hemispherical cup.
* Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.
Exclusion Criteria:
* Patients undergoing bilateral surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery.
* Patients who do not plan to return to a Cleveland Clinic surgeon for follow-up visits (i.e. out of state/country patients who may choose to follow-up with a different surgeon).
* Patients with history of radiation therapy.
* Patients with known diagnosis of Brooker grade 3 or 4 HO (heterotopic ossification) in the hip joint region.
* Patients with known diagnosis of renal disease.
* Patients with known diagnosis of osteoporosis.
* Patients with history of steroid use in the hip joint region.
* Patients that have had a previous lumbar fusion.
* Patients whose surgical reconstruction required a pelvic cage or plate.
* Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc.
* Any female of childbearing potential who is pregnant or is planning on becoming pregnant during the study period (\~2 years postoperative).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01183260
Study Brief:
Protocol Section:
NCT01183260