Femur Fracture Clinical Trial
— FLiPOfficial title:
Fracture Table vs. Lateral Positioning for Intramedullary Fixation of Femur Fractures (The FLiP Study): A Pilot Cluster Randomized Crossover Trial
NCT number | NCT03868280 |
Other study ID # | CTO 2108 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 16, 2020 |
Est. completion date | June 2023 |
The primary objective of this pilot trial is to assess the feasibility of a definitive trial to determine the effect of lateral patient positioning versus supine positioning with fracture table use for reamed antegrade intramedullary fixation of femur fractures.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 2023 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult aged 18 years or older 2. Mid shaft (Diaphyseal) femur fracture appropriate for antegrade fixation 3. Surgery performed by participating surgeon or delegate 4. Provision of informed consent 5. Enrolled within 3 weeks of femoral shaft fixation Exclusion Criteria: • 1. Ipsilateral tibial fracture 2. Bilateral femur fracture 3. Ipsilateral femoral neck fracture 4. Ipsilateral acetabular fracture 5. Periprosthetic fracture 6. Pathologic fracture 7. Previous external fixation of femoral shaft fracture 8. Inability to be positioned in lateral decubitus because of a concomitant injury 9. Pregnancy (due to decubitus positioning) 10. Incarceration 11. Expected injury survival of less than 6 months 12. Terminal illness with expected survival of less than 6 months (expected follow up of study) 13. Inability to provide informed consent (e.g. cognitive disability, language barrier, significant delirium or dementia) 14. Currently involved in study that does not permit co-enrolment 15. Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Canada | Ottawa Civic Hospital | Ottawa | Ontario |
Spain | Vall d'Hebron University Hospital | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | Canadian Institutes of Health Research (CIHR), Canadian Orthopaedic Trauma Society, Hamilton Academic Health Sciences Organization |
Canada, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility to conduct definitive Clinical Trial | Our primary outcome for the pilot trial is feasibility, which includes the following:
Recruitment (number of participants recruited across all sites over study period, goal of approximately 100 participants) Cluster crossover randomization protocol adherence Complete primary outcome collection (CT scans) on all enrolled patients. Participant retention and follow-up data Accuracy of 15 degrees as a cut off for malrotation |
Six Months | |
Secondary | Postoperative femur alignment | Immediate (within 6 weeks of surgery) post-operative bilateral computer tomography (CT scan) of the operated patients' lower extremity will be obtained as per standard of care. Postoperative bilateral CT scans for femoral shaft fractures represents the standard of care across academic centres(13). A physician familiar with musculoskeletal imaging, who is blinded to treatment allocation, will evaluate every CT for each participant. The best available literature defines clinically significant malrotation as more than 15 degrees difference from the contralateral limb in either internal or external rotation ( | Within 6 weeks of injury | |
Secondary | Health Related Quality of Life | Health-related quality of life will be assessed with the EQ-5D. The EQ-5D (27) questionnaire will be completed by participants at the time of consent and will ask about their pre-injury health status, as well as health status at the six weeks, three and six months follow up visits. The EQ-5D score represents patient reported health-related quality of life in five domains. The EQ-5D may be administered in person, over the telephone, standard mail, or electronically. | up to 6 months | |
Secondary | Modified Harris Hip Score | The modified Harris Hip Score is a limb specific functional score, which has been validated for use in other orthopedic populations, including those with total joint arthroplasty and hip fractures. The questionnaire will be completed by participants at each follow up appoints. The mHHS may be administered in person, electronically or by telephone. | up to 6 months | |
Secondary | Operative Time, Fluoroscopy Time | Operative time will be defined as the time from induction of anaesthetic and ending once the patient has procedural wounds closed, documented through operative room records. Fluoroscopy time is defined as the total time that fluoroscopy is used and is recorded on the C-Arm used for intraoperative imaging. • The pain is in the study extremity
The pain began after surgery The pain has persisted for at least three months after surgery The pain is not better explained by an infection, malignancy, a pre-existing pain condition or any other alternative cause (as judged by the treating surgeon) The severity of pain must be at least 4 on an 11-point NRS for average pain in the past week |
At time of Surgery | |
Secondary | Need for Open Reduction | Need for open reduction is defined as any secondary incision at the fracture site >5 cm. This incision facilitates open reduction and is viewed as a surrogate measure of difficulty achieving the appropriate reduction using closed manipulation. | At time of Surgery | |
Secondary | Use of Reduction Adjuncts | Use of additional reduction adjuncts is defined as use of less invasive reduction aids (e.g. reduction clamps, joystick pins, F tool, and femoral distractor) not requiring a secondary incision (>5cm) at the fracture site | At time of Surgery | |
Secondary | Operative Table Complications | Standard operative table and fracture table complications include all potential neurological injuries (e.g. pudendal, peroneal and femoral nerve palsies, etc.) and skin injuries (e.g. skin blisters, ulceration, and skin tears, etc.) derived from use of the traction boot apparatus. These will also be documented in the medical record as per standard of care. Complications will be adjudicated by a blinded member of the study team, familiar with both the injury and nature of the operation. | At time of Surgery, Up to 6 months | |
Secondary | Length of Hospital, ICU Stay | Length of hospital stay will be defined as days from admission until the day of discharge to either home, rehabilitation care, or long-term care support. Days in ICU will be recorded according to medical records. | At initial admission | |
Secondary | Days of Ventilator Support | Days of ventilator support will be defined as discrete days spent receiving any form of positive pressure ventilation, including BiPAP while extubated. | At initial admission |
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