A Safety and Technical Feasibility Evaluation of the Curvafix® Intramedullary Rodscrew System for Fixation of Pelvic and Acetabular Fractures

Not Applicable

Completed

• Conditions: Surgery - Other surgery; Pelvic ring fracture; Injuries and Accidents - Fractures; Musculoskeletal - Other muscular and skeletal disorders; Acetabular Fracture

• Registration Number: ACTRN12619000860167
• Lead Sponsor: CurvaFix, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Study Completion: 2022-08-09
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Evaluated as freedom from Serious Adverse Events (SAEs) directly attributable to the Rodscrew System.<br><br>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: <br><br>Additional fracture<br>Blood loss<br>Bone healing compromise (malunion, nonunion, delayed union)<br>Deep vein thrombosis<br>Heterotopic ossification<br>Infection<br>Nerve Damage<br>Osteonecrosis<br>Osteoarthritis<br>Pulmonary embolism<br>Pain[6-months post treatment ];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.[Procedure ]

Secondary Outcome Measures

Name	Time	Method
il[Nil]