Signature Acetabular Posterior/Lateral Data Collection

A Prospective Controlled Study on Signature Anterior Posterior/Lateral Acetabular Cup Placement System in Total Hip Arthroplasty

The primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: Cutting Guide and Conventional Instrumentation.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis; Avascular Necrosis; Noninflammatory Degenerative Joint Disease
• Intervention / Treatment: Device: Posterior Lateral Approach Total Hip Arthroplasty

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
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Room Time	Average operative time	Surgery

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 18, 2014
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (Estimate): August 20, 2014

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: hip; Signature
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases; Necrosis
• Other Study ID Numbers: ORTHO.CR.GH24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED