Clinical trial NCT02220478: Signature Acetabular Posterior/Lateral Data Collection
Official title: A Prospective Controlled Study on Signature Anterior Posterior/Lateral Acetabular Cup Placement System in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Noninflammatory Degenerative Joint Disease
Avascular Necrosis
Rheumatoid Arthritis
Keywords: hip
Signature
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 efficiency, and reducing the number of traditional instruments needed. This may reduce cost associated with the instrument inventory and instrument sterilization. Operating time may also be reduced, potentially decreasing the patient's risk of infection. However, before these hypotheses can be tested, it is important to fully understand the efficacy and accuracy of Signature Custom Guides and their use in Total Hip Arthroplasty.

Eligibility criteria: 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
* 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

Primary outcomes:
measure: Operative Room Time
timeFrame: Surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zimmer Biomet
name: Russell Schenck, Ph.D.
role: STUDY_DIRECTOR
References: