Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation

June 9, 2023 updated by: CurvaFix, Inc.

Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Performance Evaluation

Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the use and performance of the Curvafix IM intramedullary system for pelvic fixation in a post-market setting. Study participants will undergo follow-up care per institutional practice and data will then be collected from participant medical records. There will be no active patient participation requirements outside of standard of care. Any follow up evaluations will be documented and reported through 6 months post-implantation. The study will evaluate secondary surgical interventions as a primary study endpoint. Data will also be collected and analyzed for pelvic reduction stability, fracture healing, participant mobility/ambulation, and general health economics.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Memorial Medical Center, Springfield
        • Contact:
        • Principal Investigator:
          • Matthew Gardner
    • Missouri
      • Columbia, Missouri, United States, 65212
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • Mount Carmel Research institute
        • Contact:
        • Principal Investigator:
          • Ty Fowler
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health San Antonio
        • Contact:
        • Principal Investigator:
          • Ravi Karia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be selected from medical facility study sites that have agreed to participate in the study.

Description

Inclusion Criteria:

  • Subject, or their Authorized Representative, is willing and able to provide written informed consent, including authorization to release health information
  • Subject has undergone pelvic or acetabular fixation using the IM Implant and the IM Implant was placed according to the manufacturer's labeling.
  • Subject's pelvic or acetabular fixation with the IM Implant occurred within the last 30 calendar days.

Exclusion Criteria:

  • Subject is unwilling or unable to provide written informed consent and/or does not have an authorized representative who can provide consent on their behalf
  • Subject presents with any condition or situation which, in the Investigator's opinion, puts the Subject at risk, could confound the study results, or may interfere with the Subject's participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IM Implant
Male and female patients who present with a pelvic ring and/or acetabular fracture that has recently undergone surgery to be fixed with a CurvaFix IM Implant.
Device: IM Implant
Patients that have had surgical interventions with one or more IM Implant as part of standard of care for a pelvic and/or acetabular fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Surgical Interventions (SSIs)
Time Frame: 6 months post-implantation
Performance will be evaluated based upon the number of Secondary Surgical Interventions (SSIs) that occur within the subject's participation as identified through a review of subject medical records.
6 months post-implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility
Time Frame: 6 months post-implantation
Mobility (ability to advance to weight bearing) assessed by medical record review
6 months post-implantation
Pelvic Reduction Stability
Time Frame: 6 months post-implantation
Pelvic reduction stability (ability to maintain reduction over time) assessed by medical record review
6 months post-implantation
Health Economics
Time Frame: 6 months post-implantation
General health economics (length of hospital stay) assessed by medical record review
6 months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CurvaFix, Inc.

Investigators

  • Study Director: Jennifer Hebert, Clin-Assist, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-0002
  • ACTRN12622001125718 (Registry Identifier: ANZCTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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