Clinical trial NCT05606042: Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
Official title: Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Performance Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Ring Fracture
Acetabular Fracture
Pelvic Fracture
Pelvic Fracture Acetabulum
Lead sponsor: CurvaFix, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from medical facility study sites that have agreed to participate in the study.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Secondary Surgical Interventions (SSIs)
timeFrame: 6 months post-implantation
Secondary outcomes:
measure: Mobility
timeFrame: 6 months post-implantation
measure: Pelvic Reduction Stability
timeFrame: 6 months post-implantation
measure: Health Economics
timeFrame: 6 months post-implantation
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Memorial Medical Center, Springfield
state: Illinois
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
city: Columbus
country: United States
facility: Mount Carmel Research Institute
state: Ohio
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
Study officials:
affiliation: Clin-Assist, LLC
name: Jennifer Hebert
role: STUDY_DIRECTOR
References: