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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT07072832
Eligibility Criteria:
Inclusion Criteria:
* Hip dysplasia based on AP x-ray with a LCEA of \<25°
* Groin pain and/or gait abnormalities, with no other explanatory hip pathology
* Aged at least 18 years and maximal 45 years at time of surgery (indicated age for PAO(19))
* Willing to comply with the study visit schedule during 12 month follow-up
* Able and willing to provide informed consent
Exclusion Criteria:
* Previous acetabular surgery \>10yr of age
* Signs of osteoarthritis on x-ray (Tonnis classification \>1),
* Body mass index of more than 35
* Large labral tears visible on non-contrast MRI
* Pre-consultation known titanium allergy
* Pre-consultation known medical histories of diseases that per the investigator possibly affect the outcome: neuromuscular disease affecting the stability of the hip, diseases affecting bone ingrowth and fixation strength of the implant like rheumatoid arthritis and metabolic bone diseases, e.g. osteomalacie, osteoporosis, hyperparathyroidism, hypercalcemia.
* Pre-consultation known pregnant women or women who are planning to become pregnant during the duration of the study.
* Part of vulnerable population (e.g. Mentally disabled with cognitive impairment or mental disease)
* Currently participating in another investigational clinical trial.
* Unable to provide informed consent (e.g. insufficient language skills)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07072832
Study Brief:
Protocol Section:
NCT07072832