None listed
Conditions
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.
Interventions
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 st
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.
Sponsors
CurvaFix, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed