Trials Sponsors Conditions Drugs Pricing

Conditions

Acetabular Fracture Pelvic Fracture Pelvic Fracture Acetabulum Pelvic Ring Fracture

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 ImplantDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

CurvaFix, Inc.
Industrylead

Study Sites (6)

Memorial Medical Center, Springfield

Springfield, Illinois, 62781, United States

Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Mount Carmel Research Institute

Columbus, Ohio, 43219, United States

University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Prisma Health

Columbia, South Carolina, 29203, United States

UT Health San Antonio

San Antonio, Texas, 78229, United States

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

Jennifer Hebert
Clin-Assist, LLC
STUDY DIRECTOR

Enrollment

53 participants (actual enrollment reported by the registry).

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

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

IM Implant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

IM Implant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations