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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT02316704
Eligibility Criteria:
Inclusion Criteria:
* • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.
* Participants must be 18-75 years of age.
* Participants must be able to speak and understand Danish (or depending on country where patient is enrolled).
* Participants must be able to give informed consent and be cognitively intact.
* Participants must be expected to be able to complete all postoperative controls.
* Participants must not have severe comorbidities, ASA-score ≤ 3.
Exclusion Criteria:
* Terminal illness.
* Rheumatoid arthritis.
* Previous fracture of the hip.
* Osteonecrosis of the hip.
* Previous infection of the hip.
* Severe bony deformity warranting the use of non-standard implants.
* Metastasis in the periarticular bone or proximal femur.
* Female patients that are pregnant or planning pregnancy during follow-up period
* If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation.
* Documented osteoporosis with patient in active medical treatment.
* Comorbidity with altered pain perception (e.g. DM with neuropathy).
* Participants that develop deep infection in the follow-up period are excluded from the project.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02316704
Study Brief:
Protocol Section:
NCT02316704