Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001125718
Ethics application status
Approved
Date submitted
13/07/2022
Date registered
16/08/2022
Date last updated
27/06/2023
Date data sharing statement initially provided
16/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
Scientific title
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Performance Evaluation
Secondary ID [1] 306101 0
None
Universal Trial Number (UTN)
Trial acronym
RESTORE PME
Linked study record
This study is a follow-up study of ACTRN12619000860167, a safety and technical feasibility evaluation of the device.

Health condition
Health condition(s) or problem(s) studied:
Pelvic Ring Fracture
 324765 0
Acetabular Fracture 324766 0
Condition category
Condition code
Injuries and Accidents 322215 322215 0 0
Fractures
Musculoskeletal 322216 322216 0 0
Other muscular and skeletal disorders
Surgery 322217 322217 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 322512 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329979 0
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.
Timepoint [1] 329979 0
Approximately 6 months post-implantation
Secondary outcome [1] 404496 0
Mobility (ability to advance to weight bearing) assessed by medical record review
Timepoint [1] 404496 0
Approximately 6 months post-implantation
Secondary outcome [2] 412861 0
Subject Mobility/Ambulation (time to ambulation) assessed by medical record review
Timepoint [2] 412861 0
Approximately 6 months post-implantation
Secondary outcome [3] 412865 0
Pelvic reduction stability (ability to maintain reduction over time) assessed by medical record review
Timepoint [3] 412865 0
Approximately 5 months post-implantation
Secondary outcome [4] 412866 0
General health economics (length of hospital stay) assessed by medical record review
Timepoint [4] 412866 0
Approximately 6 months post-implantation

Eligibility
Key inclusion criteria
1. Subject has undergone pelvic or acetabular fixation using the IM Implant and the IM Implant was placed according to the manufacturer’s labeling.
2. Subject’s pelvic or acetabular fixation with the IM Implant occurred within the last 30 calendar days.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study is not comparative and thus empowering to make statistically valid comparisons does not apply. All results will be descriptive in nature and inferential analyses will not be conducted to assess the comparability of treatment groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
26
Final
Recruitment outside Australia
Country [1] 24473 0
United States of America
State/province [1] 24473 0
Illinois, Texas, Missouri, Ohio

Funding & Sponsors
Funding source category [1] 310444 0
Commercial sector/Industry
Name [1] 310444 0
CurvaFix, Inc.
Country [1] 310444 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CurvaFix, Inc.
Address
1406 140th Place NE, Suite 107
Bellevue, WA 98007
Country
United States of America
Secondary sponsor category [1] 311641 0
None
Name [1] 311641 0
Address [1] 311641 0
Country [1] 311641 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310083 0
Allendale IRB
Ethics committee address [1] 310083 0
30 Neck Road
Old Lyme , CT 06371
Ethics committee country [1] 310083 0
United States of America
Date submitted for ethics approval [1] 310083 0
16/06/2021
Approval date [1] 310083 0
24/06/2021
Ethics approval number [1] 310083 0
Ethics committee name [2] 313300 0
Office of the Institutional Review Board UT Health San Antonio
Ethics committee address [2] 313300 0
7703 Floyd Curl Drive
Research Administration Building
MSC 7830
San Antonio, TX 78229
Ethics committee country [2] 313300 0
United States of America
Date submitted for ethics approval [2] 313300 0
Approval date [2] 313300 0
13/09/2022
Ethics approval number [2] 313300 0
20220502HU
Ethics committee name [3] 313301 0
Institutional Review Board University of MIssouri-Columbia
Ethics committee address [3] 313301 0
310 Jesse Hall
Columbia, MO 65211
Ethics committee country [3] 313301 0
United States of America
Date submitted for ethics approval [3] 313301 0
Approval date [3] 313301 0
27/02/2023
Ethics approval number [3] 313301 0
390123
Ethics committee name [4] 313302 0
Mount Carmel Health Systm Institutional Review Board
Ethics committee address [4] 313302 0
3100 Easton Square Place
Columbus, Ohio 43219
Ethics committee country [4] 313302 0
United States of America
Date submitted for ethics approval [4] 313302 0
Approval date [4] 313302 0
13/02/2023
Ethics approval number [4] 313302 0
221227-4

Summary
Brief summary
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116422 0
Dr Matthew Gardner
Address 116422 0
Springfield Clinic
701 North 1st Street
Springfield, IL 62781
Country 116422 0
United States of America
Phone 116422 0
+1 217 528 7541
Fax 116422 0
Email 116422 0
[email protected]
Contact person for public queries
Name 116423 0
Jennifer Hebert
Address 116423 0
Clin-Assist, LLC
1141 Gravenstein Highway South
Sebastopol, CA 95472
Country 116423 0
United States of America
Phone 116423 0
+1 650 400 1837
Fax 116423 0
Email 116423 0
[email protected]
Contact person for scientific queries
Name 116424 0
Jennifer Hebert
Address 116424 0
Clin-Assist, LLC
1141 Gravenstein Highway South
Sebastopol, CA 95472
Country 116424 0
United States of America
Phone 116424 0
+1 650 400 1837
Fax 116424 0
Email 116424 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.