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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT02518269
Eligibility Criteria:
Inclusion Criteria:
Patient is 18 to 75 years of age, inclusive.
* Patients determined to be suitable for uncemented fixation by investigator
* Patient is skeletally mature.
* Patient qualifies for primary unilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:
* Osteoarthritis (OA)
* Developmental Dysplasia without subluxation
* Patient is willing and able to provide written informed consent.
* Patient is willing and able to cooperate in the required post-operative therapy.
* Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
Exclusion Criteria:
The patient is:
* A prisoner
* Mentally incompetent or unable to understand what participation in the study entails
* A known alcohol or drug abuser
* Anticipated to be non-compliant.
* The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
* The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
* The patient is known to be pregnant.
* The patient is unwilling or unable to give informed consent, or to comply with the follow-up program.
* The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
The patient has had previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
* The patient has insufficient bone stock to fix the component. Insufficient bone stock exists (ex: Dorr type C) in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation.
* Estimated cup size smaller than 48 or stem size smaller than 7
* The patient has known local bone tumors in the operative hip.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02518269
Study Brief:
Protocol Section:
NCT02518269