Signature Acetabular Posterior/Lateral Data Collection (NCT02220478) | Clinical Trial Compass
TerminatedNot Applicable
Signature Acetabular Posterior/Lateral Data Collection
Stopped: Unable to engage surgeons to participate in the study
24 participantsStarted 2014-11
Plain-language summary
The primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: Cutting Guide and Conventional Instrumentation.
Who can participate
Age range20 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with one of the following indication:
* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis.
* Correction of functional deformity.
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Additional inclusion criteria include:
* Subjects requiring primary total hip arthroplasty
* 20 to 75 years of age
* Subjects with a diagnosis of osteoarthritis or traumatic arthritis
* Subjects willing to return for follow-up evaluations.
* Subjects who can read, understand study information and give written consent without representation of a legally authorized representative.
* Bilateral patients are included if staged.
* Only Posterior Lateral Approach can be used for inclusion in this study
Exclusion Criteria:
\- Exclusion criteria should be in accordance with Contraindications for the Biomet primary acetabular cup.
Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
Additional contraindications include:
* Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, and severe forms of multiple epiphyseal dysplasia
* Subjects unable to cooperate with and complete the study
* Dement…