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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT03833258
Eligibility Criteria:
Inclusion Criteria:
* Adult participants over the age of 18 years will be included.
* All participants should be proceeding with routine care unilateral (one side only) primary THR for treatment of osteoarthritis
* The patients operating consultant agreed to involvement of their patients in the study.
* All subjects assessed during routine pre-operative assessment in their respective hospital will have been assigned an American Society of Anesthesiologists (ASA) up to grade 3 out of a total of 6 (defined as 'severe systemic disease that limits activity but is not incapacitating').
* Patients who have undergone previous hip injection for treatment of osteoarthritic symptoms.
* All surgical approaches (anterior, lateral and posterior), cemented and un-cemented prostheses and all size femoral head size.
Exclusion Criteria:
* The operating consultant declined participation in the study.
* The participant previously had hip surgery to the same hip, including arthroscopy, revision hip surgery or treatment for Avascular Necrosis.
* ASA grade 4 or above 'A patient with severe systemic disease that is a constant threat to life.'
* Patients with specifically identified increased risk of dislocation (for example neuromuscular disease, hypermobility)
* Complex primary hip replacement (THR with femoral osteotomy or structural bone grafting / augmentation of acetabulum)
* Patients unable to complete the postal outcome measures.
* Any patient with pre-operative cognitive impairment (Dementia or Learning disabilities).
* Patients undergoing THR for treatment of fractured neck of femur.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03833258
Study Brief:
Protocol Section:
NCT03833258