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

Acetabular Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606042
• Other study ID #: CLP-0002
• Secondary ID: ACTRN12622001125
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acetabular Fracture
• Fractures, Bone
• Hip Fractures
• Pelvic Fracture
• Pelvic Ring Fracture

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