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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01289834
Eligibility Criteria:
Inclusion Criteria:
* primary hip osteoarthritis
* sufficient bone quality for total hip arthroplasty
* age 71 years and above
* no upper age limit if the patient is capable
* informed and written consent
* patient can only enter the project with one hip
Exclusion Criteria:
* planned bilateral hip surgery
* neuromuscular or vascular disease in the affected leg
* preoperatively not found suitable for a hip arthroplasty
* patients with osteoporosis based on former diagnosis or preoperative DEXA-scan
* fracture sequelae, osteonecrosis or previous extensive hip surgery
* patients who cannot refrain from taking NSAID post-operatively
* continuous medical treatment with vitamin K antagonists (Warfarin) which is known to reduce the bone mass by a factor of 5
* patients with metabolic bone disease
* patients with rheumatoid arthritis
* postmenopausal women in systemic estrogenic hormone substitution
* patients with a continuous need of systemic cortisone treatment
* non-Danish citizenship
* patients who do not comprehend the Danish language (read and speak)
* senile dementia
* alcoholism - defined as men drinking more than 21 units a week and women drinking more than 14 units a week
* drug abuse
* major psychiatric disease
* metastatic cancer disease and treatment with radiation therapy or chemotherapy
* severe systemic disease (e.g. hemi paresis and Parkinson disease)
* systemic hip and spine disease
* employee at the orthopaedic department, Aarhus University Hospital
* ongoing case regarding industrial injury insurance of the knee
* patients with poor dental status (risk of infection)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
71 Years
Study:
NCT01289834
Study Brief:
Protocol Section:
NCT01289834