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Trial registered on ANZCTR


Registration number
ACTRN12619000860167
Ethics application status
Approved
Date submitted
16/05/2019
Date registered
17/06/2019
Date last updated
14/03/2023
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Safety and Technical Feasibility Evaluation of the Curvafix® Intramedullary Rodscrew System for Fixation of Pelvic and Acetabular Fractures
Scientific title
A Safety and Technical Feasibility Evaluation of the Curvafix® Intramedullary Rodscrew System for Fixation of Pelvic and Acetabular Fractures
Secondary ID [1] 297793 0
Nil known
Universal Trial Number (UTN)
U1111-1230-6625
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic ring fracture 312139 0
Acetabular Fracture 312956 0
Condition category
Condition code
Injuries and Accidents 310693 310693 0 0
Fractures
Musculoskeletal 311452 311452 0 0
Other muscular and skeletal disorders
Surgery 311453 311453 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intramedullary Rodscrew System, manufactured by CurvaFix, Inc., is a flexible intramedullary implant designed to provide fracture fixation for unstable disruptions of the pelvic ring and acetabulum. One or more rodscrew implants are surgically implanted into the intramedullary space of the pelvic bone during a single procedure. The procedure will take approximately 2 to 4 hours, and will take place in an operating room under anesthesia. The implant will be administered by a surgeon. The study doctor (surgeon) and staff will be trained to perform the procedure following the device's Instructions for Use (IFU). The Study Sponsor will monitor the procedure to ensure it is completed correctly, per the protocol and IFU.
Intervention code [1] 314031 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319546 0
Primary Safety Endpoint: Evaluated as freedom from Serious Adverse Events (SAEs) directly attributable to the Rodscrew System.

The primary safety endpoint will be evaluated by adverse event data reported by the Investigator up to six (6) months post procedure. Examples of possible adverse events include:

Additional fracture
Blood loss
Bone healing compromise (malunion, nonunion, delayed union)
Deep vein thrombosis
Heterotopic ossification
Infection
Nerve Damage
Osteonecrosis
Osteoarthritis
Pulmonary embolism
Pain
Timepoint [1] 319546 0
6-months post treatment
Primary outcome [2] 319547 0
Number of implants which achieve 'technical success': Evaluated based upon the successful implantation of the rodscrew in the intended fixation site as judged by the operator and confirmed radiographically.
Timepoint [2] 319547 0
Procedure
Secondary outcome [1] 368629 0
Nil
Timepoint [1] 368629 0
Nil

Eligibility
Key inclusion criteria
1. Subject, or their Authorized Representative, is willing and able to provide written informed
consent, including authorization to release health information
2. Subject is >18 years and < 70 years of age (inclusive) at time of consent
3. Subject has an unstable pelvic or acetabular displaced fracture in which fixation with one
or more large cannulated screw(s) is recommended
4. Subject’s pelvic or acetabular fracture occurred (injury) within 14 days of procedure
5. Subject has provided a negative pregnancy test (if of child bearing age or potential) and
is willing to continue an effective method of birth control through study end (6 months)
6. Subject is a suitable candidate for cannulated screw fixation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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
2. Subject has an open pelvic or acetabular fracture (where the bone is exposed)
3. Subject has an active significant or local infection at the time of the procedure that may compromise study results (for example, a sinus infection would not be considered an exclusion)
4. Subject has muscular deficit, neurological deficiency, or behavioral disorders which could submit the osteosynthesis to abnormal mechanical strains
5. Subjects has malignant primary or metastatic cancer or subject has undergone recent chemotherapy or other treatment that have resulted in compromised bone density
6. Subject has a tumor(s) which precludes adequate bone support or screw fixation(s)
7. Subject has a sensitivity or uncontrollable allergy to the study device or other materials necessary to perform the procedure
8. Subject’s pelvis intracortical space is not large enough to accommodate the study device
9. Subject’s pelvic and/or acetabular size and/or shape is not appropriate for CurvaFix implantation
10. Subject has had previous pelvic ring and/or acetabular surgery which mechanically precludes the implantation of a rodscrew
11. Subject has a history of osteoporosis that is considered severe or, in the opinion of the physician, would compromise study results
12. The fracture pattern is not appropriate for intramedullary fixation (e.g. posterior or anterior wall fractures in isolation)
13. Subject plans to have additional surgical procedure(s) within 6 months of the CurvaFix procedure that in the opinion of the investigator would interfere with study results
14. Subject is considered obese or morbidly obese and/or with a body shape that prevents the necessary pelvic access
15. Subject has a vascular injury at the fracture site that the investigator feels could interfere with the procedure
16. Subject is under incarceration or the subject’s fracture injury is or may be related to criminal activity
17. Subject is pregnant, nursing, or plans to become pregnant during the study, or is not willing to use an effective method of birth control (if of child bearing age and potential)
18. Subject is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the investigator would interfere with the study results
19. 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 of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This study will use descriptive statistics. The study is not comparative and thus powering 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
Completed
Date of first participant enrolment
Anticipated
21/06/2019
Actual
17/09/2019
Date of last participant enrolment
Anticipated
20/12/2019
Actual
3/02/2022
Date of last data collection
Anticipated
30/06/2020
Actual
9/08/2022
Sample size
Target
39
Accrual to date
Final
26
Recruitment outside Australia
Country [1] 21370 0
Canada
State/province [1] 21370 0
British Columbia
Country [2] 21371 0
United States of America
State/province [2] 21371 0
Texas
Country [3] 21372 0
United States of America
State/province [3] 21372 0
Ohio
Country [4] 25324 0
United States of America
State/province [4] 25324 0
Mississippi
Country [5] 25325 0
United States of America
State/province [5] 25325 0
California
Country [6] 25326 0
United States of America
State/province [6] 25326 0
South Carolina

Funding & Sponsors
Funding source category [1] 302316 0
Commercial sector/Industry
Name [1] 302316 0
CurvaFix, Inc.
Country [1] 302316 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] 302197 0
None
Name [1] 302197 0
Not Applicable
Address [1] 302197 0
Not Applicable
Country [1] 302197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302989 0
University of British Columbia - Office of Research Ethics
Ethics committee address [1] 302989 0
Room 210, Research Pavilion
828 West 10th Avenue
Vancouver, BC Canada V5Z 1L8
Ethics committee country [1] 302989 0
Canada
Date submitted for ethics approval [1] 302989 0
20/03/2019
Approval date [1] 302989 0
30/05/2019
Ethics approval number [1] 302989 0
H18-02775
Ethics committee name [2] 312615 0
BRANY IRB
Ethics committee address [2] 312615 0
1981 Marcus Avenue, Suite 210
Lake Success, NY 11042
Ethics committee country [2] 312615 0
United States of America
Date submitted for ethics approval [2] 312615 0
22/05/2019
Approval date [2] 312615 0
21/06/2019
Ethics approval number [2] 312615 0
2019-565

Summary
Brief summary
This is a prospective, multi-center, single-arm (non-randomized), study to evaluate the safety and technical success of the CurvaFix® Intramedullary Rodscrew System.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92090 0
Dr Amir Matityahu
Address 92090 0
San Jose Regional Medical Center
1001 Potrero Avenue
San Francisco, CA 94110
Country 92090 0
United States of America
Phone 92090 0
+1 4083474046
Fax 92090 0
Email 92090 0
[email protected]
Contact person for public queries
Name 92091 0
Jennifer Hebert
Address 92091 0
Clin-Assist, LLC
1141 Gravenstein Highway South
Sebastopol, CA 95472
Country 92091 0
United States of America
Phone 92091 0
+1 650 400 1837
Fax 92091 0
Email 92091 0
[email protected]
Contact person for scientific queries
Name 92092 0
Jennifer Hebert
Address 92092 0
Clin-Assist, LLC
1141 Gravenstein Highway South
Sebastopol, CA 95472
Country 92092 0
United States of America
Phone 92092 0
+1 650 400 1837
Fax 92092 0
Email 92092 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
Line by line patient data will not be publicly available. Summary data and resulting analyses will be publicly available should the study results be published.


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.