Status:
TERMINATED
Signature Acetabular Posterior/Lateral Data Collection
Lead Sponsor:
Zimmer Biomet
Conditions:
Noninflammatory Degenerative Joint Disease
Avascular Necrosis
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief 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.
Detailed Description
Using a more advanced surgical technique may assist surgeons and patients in a variety of ways including identifying a specific-size for the prosthesis prior to surgery, increasing operating room effi...
Eligibility Criteria
Inclusion
- 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
- \- 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
- Dementia and inability to understand and follow instructions
- Neurological conditions affecting movement
- Pregnancy
- Additional exclusion criteria include:
- Surgical approach other than posterior lateral.
- Simultaneous bilateral procedures
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02220478
Start Date
November 1 2014
End Date
July 1 2016
Last Update
October 25 2022
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