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 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT04358250
Eligibility Criteria:
Inclusion Criteria:- Patients affected by:
* Non-inflammatory degenerative joint disease, including osteoarthritis
* Patients in the age from 60 to 85 included
* Consenting to actively participate in the study and in the rehabilitation follow up program as foreseen by the study
* 18 ≤ Body Mass Index (BMI) ≥ 30 kg/m2
* patient without contralateral THA
Exclusion Criteria:-Revision procedures where other treatments or devices have failed
* Active infection or suspected latent infection in or about the hip joint
* Bone stock that is inadequate for support or fixation of the prosthesis
* skeletal immaturity
* any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complication in post-operative care
* Obesity (BMI ≥30kg/m2)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT04358250
Study Brief:
Protocol Section:
NCT04358250