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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT05679232
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent signed by the subject
* Males and females aged over 18 years at time of surgery
* Subjects who are scheduled to receive a conical collarless cementless revision hip arthroplasty, with or without revision of the acetabular cup
* Subjects willing to comply with the pre- and post-operative evaluation schedule
Exclusion Criteria:
* Subjects with one or more medical conditions identified as a contraindication defined by the labelling on any implants used in this study
* Subjects with immune suppressive treatment for organ transplantation, or known allergy to MectaShield hydrogel constituents (Chitlac, Mannitol, Hydroxypropylmethylcellulose, Sodium phosphate dibasic)
* Subjects presenting with progressive local or systemic infection at the time of surgery
* Subjects whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
* Subjects affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity
* Subjects unable to understand and take action
* Subjects undergoing cementless revision hip arthroplasty in emergency interventions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05679232
Study Brief:
Protocol Section:
NCT05679232