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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT02061904
Eligibility Criteria:
Inclusion Criteria:
1. revision hip arthroplasty with acetabular defects eligible for bone impaction grafting
2. Diagnosis: acetabular osteolytic defects after primary total hip arthroplasty, planned for revision hip arthroplasty with bone impaction grafting.
3. Patient is between 35 and 75 years old.
4. Patient is expected to recover completely.
5. Patient is willing and able to come to follow-up examinations.
6. Patient has signed an informed consent.
Exclusion Criteria:
1. Infection of the hip joint or distant infection (may cause hematogenous spread to the implant site)
2. Hip fractures
3. Patient is younger than 35 years or older than 75 years.
4. Patient is not willing and/or able to come to follow-up examinations
5. Patient has not signed an informed consent
6. Pregnancy
Relative contra-indications:
With regard to the patient's general health:
1. Metabolic disorders or medication (e.g. steroids) which may impair bone formation
2. Osteomalacia
3. Disorders of the immune system, caused by disease or immunosuppressive medication which increase the risk of infection.
4. Poor prognosis for good wound healing: decubitus ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT02061904
Study Brief:
Protocol Section:
NCT02061904