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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT05007067
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, as per indications for use, in 2019 onwards
* Age ≥ 18 years old
* Subjects who have signed the written informed consent approved by the reference Ethics Committee (EC)
* Subjects able to comply with the protocol and to perform all scheduled follow-up visits
Exclusion Criteria:
* Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, but showed any of the contraindications reported in the Instruction for Use
* Age \< 18 years old
* Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to:
1. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery.
2. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device.
3. known metabolic disorders leading to progressive bone deterioration.
* Hip replacement on the contralateral side performed within less than one year.
* Female subjects who are pregnant, nursing or planning a pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05007067
Study Brief:
Protocol Section:
NCT05007067