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

Last updated: June 9, 2023
Sponsor: CurvaFix, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

IM Implant

Clinical Study ID

NCT05606042
CLP-0002
ACTRN12622001125718
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject, or their Authorized Representative, is willing and able to provide writteninformed consent, including authorization to release health information
  • Subject has undergone pelvic or acetabular fixation using the IM Implant and the IMImplant 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

Exclusion Criteria:

  • Subject is unwilling or unable to provide written informed consent and/or does nothave 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 theSubject's participation in the study

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: IM Implant
Phase:
Study Start date:
November 24, 2021
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Memorial Medical Center, Springfield

    Springfield, Illinois 62781
    United States

    Active - Recruiting

  • Missouri Orthopaedic Institute

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Mount Carmel Research Institute

    Columbus, Ohio 43219
    United States

    Active - Recruiting

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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