A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures Modern Ring External Fixators vs. Internal Fixation (FIXIT Study)

Study ID
STU 062011-041

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Cynthia Wright
214-645-3367
cynthia.wright@utsouthwestern.edu

Principal Investigator
Medardo Maroto

Summary

Patients will be randomized to one of the 2 treatment groups prior to the time of definitive fixation. the success of the study hinges on an ability to successfully enroll and randomized patients. This study is more challenging than most as the two treatment arms will likely be preceived as different to the patients, potentially lowering patient willingness to be randomized. To promote higher enrollment rate, the consent protocol will directly involve the patient's treating surgeon. even with these efforts, there will likely be a significant number of patients who refuse randomization but are willing to participate in the study. These patients will be enrolled in a prospective cohort study as has been done in other large surgical randomized studies.
Patients will be asked to participate in 5 follow-up visits at 6,12,26 an 52 weeks after definitive treatment of the injury. The primary outcome is hospital readmissions for complications. Secondary outcomes include infection, functional outcome, and patient reported outcomes.
Screening-Patients will be screened for eligibility in each center by the local research coordinator in close coordination with the surgeon co-investigators. Screening will typically occur with the first day or two after the initial debridement and placement of a temporary external fixation and prior to definitive fixation. all potentially eligible patients will be entered into ReDCap, a study number assigned, adn eligibility criteria confirmed.
Randomization-one the eligibility of the patient for study inclusion has been determined and the patient as beens consented with assistance from the treating surgeon, the Research Coordinator will update the ReDCap Data Management System and the patient will be randomized electronically to one of two groups:
Group 1: Definitive fixation with a ring fixator
Group 2: Definitive fixation with a locked iM nail or plate
Treatments:Patients with bone defects that are treated using distraction osteogenesis will use standard techniques, with minor details of the process left to the discretion of the treating surgeon. Patients with bone defect that are treated with delayed bone grafting will use standard protocols, with details left to the discretion of the treating surgeon. Defects will typically be treated with antibiotic impregnated polymehthyl methatcralate spacer to induce a vascularized [Quote]biomembrane[Quote] around the bone defect. Four to six weeks later the biomembrane is opend, the spacer removed, and the void is filled with bone graft. The type of graft, how it is harvested, and the use of bone morphogenic proteins to augment the healing will be at the discretion of the treating surgeon, consistent with current clinical practice.
Some patients who randomize to the ring external fixator may be judged by the treating surgeon to poetentially not require a flap if the limb were shortened acutely and then lengthened again once the soft tissue has stabilized. The decision to attempt this technique will be left to the treating surgeon, as will all other technical details of the two treatment arms.
Patients will receive $25 for completing each of the first 4 follow-up visits and $50 for completing the final visit at 12 months after his/her surgery. These payments are in appreciation of the patient time and effort.

Participant Eligibility

All open tibia fractures meeting at least one of the following criteria:
1a. Diaphyseal or metaphyseal Type IIIB (Gustilo IIIB Fractures are open fractures that require either a rotational or free flap for coverage of a soft tissue defect).
b.Diaphyseal or metaphyseal Type IIIA where extensive contamination or muscle damage (e.g. all military injuries from IED) precludes nail/plate placement at first debridement.
c. Diaphyseal or metaphyseal Type IIIA, where injury would have been classified as a IIIB, but because enough muscle was removed, the skin could be closed.
d. Diaphyseal or metaphyseal Type IIIA, where after debridement, bone gap is greater than 1cm.
e. Diaphyseal or metaphyseal Type IIIA, where fasiotomies were performed for impending or diagnosed compartment syndrome, and wounds could not be closed primarily (i.e. needs skin grafting.
2. Ages 18-64 years inclusive
3.Study fracture is suitable for limb salvage using either a modern ring external fixator or internal fixation (internal fixation =locked intramedullary nail or plate).
4. Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
5. Patients may have risk factors for infection including diabetes, immunosuppression from steriods or other medications, HIV, or other infections.
6.Patients may have a traumatic brain injury.
7.Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip femur or foot injuries.
8. Patients may be treated initially with a temporary external fixator prior to randomization.
9. Patients may be treated initially at an outside institution prior to transfer to the stud institution, as long as the definitive fixation was not performed prior to entrance into the study.
10.Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more sever" by the treating surgeon will be enrolled in the study.
11.Fractures may have a gap after debridement of any size, including no gap.