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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT05854056
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic patella alta with recurrent dislocation or subluxation. Long-lasting anterior knee pain not responding to rehabilitation.
Exclusion Criteria:
Radiographic:
* Open growth plates
* Iwano \[8\] grade III and IV changes in patellofemoral joint
* Caton-Deschamps \<1.1 in MRI
* PTI \>50% in MRI
* High grade trochlear dysplasia
General:
* Refuses to participate in the study
* Aged less than 15 or more than 35 years
* Severe neurological, pulmonal or cardiovascular comorbidities that are contraindications for surgery
* Lack of adequate co-operation
* Does not adequately understand written and spoken instructions in the local language
Those patients who decline to take part in the trial will be asked to join a follow-up cohort as a background population. The patients in this follow-up cohort will be treated "as normal" without allocation, but the follow-up questionnaires will be the same as those given to the randomly assigned population. The patients in the follow-up cohort will also be asked to provide informed written consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
35 Years
Study:
NCT05854056
Study Brief:
Protocol Section:
NCT05854056