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

CurvaFix

Status: Enrolling

Conditions: Pelvic Fracture Acetabulum; Acetabular Fracture; Pelvic Ring Fracture; Pelvic Fracture

Treatments: Device: IM Implant

Study type: Observational

Funder types: Industry

Identifiers

NCT05606042

ACTRN12622001125718 (Registry Identifier)

CLP-0002

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

IM Implant

Description:

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.

Treatment:

Device: IM Implant