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Signature Acetabular Posterior/Lateral Data Collection

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ClinicalTrials.gov Identifier: NCT02220478
Recruitment Status : Active, not recruiting
First Posted : August 20, 2014
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment Phase
Noninflammatory Degenerative Joint Disease Avascular Necrosis Rheumatoid Arthritis Device: Posterior Lateral Approach Total Hip Arthroplasty Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Controlled Study on Signature Anterior Posterior/Lateral Acetabular Cup Placement System in Total Hip Arthroplasty
Study Start Date : November 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Signature Cutting Guides
Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.
Device: Posterior Lateral Approach Total Hip Arthroplasty
All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.
Active Comparator: Conventional Instrumentation
Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.
Device: Posterior Lateral Approach Total Hip Arthroplasty
All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.



Primary Outcome Measures :
  1. Radiographic evaluations to compare planned cup position to final cup position [ Time Frame: 0-6 Weeks ]
    Radiographic evaluations will be collected post-operatively between 0 and 6 weeks and compared to planned implantation


Secondary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: Operative - 6 months post operative ]
    Dislocations and other serious adverse events

  2. Operative Room Time [ Time Frame: Operative ]
    Time from Operation Start to Suture Closing



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220478


Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Russell Schenck, Ph.D. Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02220478     History of Changes
Other Study ID Numbers: ORTHO.CR.GH24
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
hip
Signature

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Necrosis
Joint Diseases
Osteoarthritis
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes