| Protocol Number: |
Version 1.0 |
| Trial Phase: |
Phase I |
| Maximum # of Subjects: |
144 |
| IRB Number: |
UL# 207.04 |
| Study Status: |
Active |
| Enrollment Status: |
Open |
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(Permission not yet granted to post information on web)
To gather clinical and radiographic data on a new modular total hip system used for the cementless revision of failed femoral prostheses with or without accompanying ancillary component revision (i.e. acetabular component)
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Eligibility |
Inclusion Criteria: 1. Candidates for cementless revision of a failed femoral prosthesis.
2. Patients willing to sign the informed consent.
3. Patients able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations.
4. Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery. |
Exclusion Criteria: 1. Patients with ongoing infection.
2. Patients who are severely immunocompromised.
3. Patients who are prisoners. |
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