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

NCT05606042 | Terminated FDA Device

• 2 other identifiers: CLP-0002ACTRN12622001125718
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Pelvic Ring Fracture; Acetabular Fracture; Pelvic Fracture; Pelvic Fracture Acetabulum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mobility

  6 months post-implantation

• Pelvic Reduction Stability

  6 months post-implantation

• Health Economics

  6 months post-implantation

Study Arms (1)

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

Interventions

IM Implant DEVICE

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

IM Implant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CurvaFix, Inc.: lead

Study Sites (6)

Memorial Medical Center, Springfield

Springfield, Illinois, 62781, United States

Location

Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

Mount Carmel Research Institute

Columbus, Ohio, 43219, United States

Location

University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Prisma Health

Columbia, South Carolina, 29203, United States

Location

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Jennifer Hebert

  Clin-Assist, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 4, 2022
• Study Start: November 24, 2021
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: March 20, 2026

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)