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Signature Acetabular Posterior/Lateral Data Collection

Primary Purpose

Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Rheumatoid Arthritis

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Posterior Lateral Approach Total Hip Arthroplasty

About this trial

This is an interventional treatment trial for Noninflammatory Degenerative Joint Disease focused on measuring hip, Signature

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Signature Cutting Guides

Conventional Instrumentation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Operative Room Time

Average operative time

Secondary Outcome Measures

Full Information

NCT ID

NCT02220478

First Posted

August 18, 2014

Last Updated

September 30, 2022

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT02220478

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why Stopped

Unable to engage surgeons to participate in the study

Study Start Date

November 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Rheumatoid Arthritis

Keywords

hip, Signature

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Signature Cutting Guides

Arm Type

Active Comparator

Arm Description

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

Arm Title

Conventional Instrumentation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Posterior Lateral Approach Total Hip Arthroplasty

Intervention Description

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 Measure Information:

Title

Operative Room Time

Description

Average operative time

Time Frame

Surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Russell Schenck, Ph.D.

Organizational Affiliation

Zimmer Biomet

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Signature Acetabular Posterior/Lateral Data Collection

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