Signature Acetabular Posterior/Lateral Data Collection

NCT ID: NCT02220478

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-07-31

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.

Conditions

Noninflammatory Degenerative Joint Disease; Avascular Necrosis; Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Signature Cutting Guides

Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.

Group Type: ACTIVE_COMPARATOR

Posterior Lateral Approach Total Hip Arthroplasty

Intervention Type: DEVICE

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.

Conventional Instrumentation

Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.

Group Type: ACTIVE_COMPARATOR

Posterior Lateral Approach Total Hip Arthroplasty

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• 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

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

• Surgical approach other than posterior lateral.
• Simultaneous bilateral procedures

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Schenck, Ph.D.

Role: STUDY_DIRECTOR

Zimmer Biomet

Other Identifiers

ORTHO.CR.GH24

Identifier Type: -

Identifier Source: org_study_id