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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT01807104
Eligibility Criteria:
Inclusion Criteria:
1. Subject is able to or capable of providing consent to participate in the clinical investigation.
2. Subject is between the ages of 20-75 years, inclusive.
3. Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)
4. Subject has sufficient bone stock for the hip replacement device.
5. Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either surgical approach.
Exclusion Criteria:
1. Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.
2. Subject has had previous surgery on the affected hip.
3. Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01807104
Study Brief:
Protocol Section:
NCT01807104