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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05606042
Other study ID # CLP-0002
Secondary ID ACTRN12622001125
Status Recruiting
Phase
First received
Last updated
Start date November 24, 2021
Est. completion date June 2024

Study information

Verified date June 2023
Source CurvaFix, Inc.
Contact Jennifer Hebert
Phone 16504001837
Email jennifer@clin-assist.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Missouri Orthopaedic Institute Columbia Missouri
United States Mount Carmel Research Institute Columbus Ohio
United States UT Health San Antonio San Antonio Texas
United States Memorial Medical Center, Springfield Springfield Illinois

Sponsors (1)

Lead Sponsor Collaborator
CurvaFix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Secondary Surgical Interventions (SSIs) 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 Mobility Mobility (ability to advance to weight bearing) assessed by medical record review 6 months post-implantation
Secondary Pelvic Reduction Stability Pelvic reduction stability (ability to maintain reduction over time) assessed by medical record review 6 months post-implantation
Secondary Health Economics General health economics (length of hospital stay) assessed by medical record review 6 months post-implantation
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