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Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. Patients will be randomized by an Excel random number generator to a tourniquet and non-tourniquet group. Patients will remain blinded to randomization. The treating orthopaedic trauma surgeon will be notified by the PI of the study informing them of the randomization status to ensure appropriate tourniquet utilization the day of surgery. Patients will then undergo standard operative fixation and postoperative management as clinically indicated by the orthopaedic trauma team. Patients will follow-up at 2 weeks and subsequently every 4 weeks as is protocol at our institution. Patient charts will be reviewed for patient and perioperative factors, as well as postoperative complications (i.e. wound complications, need for repeat surgical intervention, and deep vein thrombosis).
Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. II.
Tourniquet utilization in the operative fixation of ankle fractures remains controversial and is often subject to surgeon preferences. Despite postulated benefits of minimizing blood loss, decreasing operative times, and improving visualization, tourniquets in ankle fracture fixation have been associated with increased postoperative pain, swelling, decreased range of motion, and increased opioid consumption. Previous literature has demonstrated a nonsignificant increase in wound infections and deep vein thrombosis (DVT) with tourniquet usage. Changes in perfusion intraoperatively and effects of ischemic reperfusion injury have been theorized as drivers of these negative side effects of tourniquets. Perfusion following ankle fracture fixation, thus represents an opportunity to better understand the physiologic implications of tourniquet utilization.
Tourniquet use is associated with negative outcomes after total knee arthroplasty (TKA). Despite decreased blood loss, tourniquet use in TKA has been associated with higher VAS pain scores, decreased knee range of motion and functional scores in the early postoperative period, higher rates of thrombotic events, infection, and reoperation. Impaired prosthesis survival, knee function, blood transfusion rates, quality of life, and patient satisfaction bring into question the utility of tourniquet use in TKA. These outcomes have not been thoroughly investigated in the fixation of ankle fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tourniquet Group | Experimental | Patients randomized to this group will have a tourniquet used during the operative fixation of their ankle fracture. Tourniquets will be inflated to 250 mmHg as is standard for our institution. Tourniquet will be deflated at time of closure. |
|
| No Tourniquet Group | Other | Patients randomized to this group will not have a tourniquet used during operative fixation of their ankle fracture. A tourniquet will be placed on the patient's operative extremity as a safety precaution, but will remain deflated for the duration of the procedure unless emergently needed for hemostasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tourniquet | Device | Tourniquets will be applied to the thigh of the operative extremity during operative fixation of ankle fractures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Pain Levels | VAS pain scores (0-10) will be assessed for the ankle immediately postoperatively in the post anesthesia care unit and at 2 weeks, 6 weeks and 3 months postoperatively. | Post anesthesia recovery unit, 2 weeks postoperatively, 6 weeks, 3 month follow-up |
| Patient-Reported Outcome Measurement Information System (PROMIS) Cat V1.1 Pain Interference scores | Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V1.1 Pain Interference (10-90, lower is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow. | 6 weeks, 3 months |
| Patient-Reported Outcome Measurement Information System (PROMIS) Cat V2.0 Physical Function Score | Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V2.0 Physical Function (10-90, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow. | 6 weeks, 3 month |
| Patient-Reported Outcome Measurement Information System (PROMIS) Scale V1.2 Global Health Score | Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Scale V1.2 Global Health (15-70, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow. | 6 weeks, 3 months |
| Optimal Screening for Prediction of Referral and Outcome (OSPRO) Yellow Flag 17-Item | OSPRO-Yf 17 questionnaires will be completed at follow-up appointments as part of standard trauma clinic workflow and will be assessed at 6 weeks, and 3 months. | 6 weeks, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications | Postoperative complications following operative fixation of ankle fractures will be assessed at follow-up appointments and through chart review. Complications include postoperative deep vein thrombosis, wound complications and infection (patients receiving antibiotics or requiring surgical irrigation and debridement), need for revision fixation or hardware removal. | 6 months |
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Inclusion criteria:
Exclusion criteria:
e) Active anticoagulation/bleeding disorder necessitating tourniquet use (Hemoglobin <7, PT >13, PTT>35) f) Ipsilateral lower extremity trauma impacting immobilization g) Patients with peripheral neuropathy h) Patients undergoing ankle arthroscopy
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| Name | Affiliation | Role |
|---|---|---|
| Alex Demers, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52245 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24602486 | Background | Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Mar 6;9(1):13. doi: 10.1186/1749-799X-9-13. | |
| 32116012 | Background | Benedick A, Rivera T, Vallier HA. Effect of Tourniquet Use During Ankle Fracture Fixation on Wound Healing and Infectious Complications. Foot Ankle Int. 2020 Jun;41(6):714-720. doi: 10.1177/1071100720907379. Epub 2020 Mar 1. |
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IPD will not be shared secondary to data sharing regulations at our institution.
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| D010146 | Pain |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D014111 | Tourniquets |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Patients undergoing operative fixation of ankle fractures will be randomized to the tourniquet and no tourniquet groups in a 1:1 fashion. The treating orthopaedic trauma surgeon will be informed of the randomization status the day of surgery by the PI to ensure appropriate tourniquet utilization is executed during surgery.
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| No Tourniquet | Other | No tourniquet will be inflated on the operative extremity during the operative fixation of ankle fractures. |
|
| 15805957 | Background | Konrad G, Markmiller M, Lenich A, Mayr E, Ruter A. Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94. doi: 10.1097/01.blo.0000151849.37260.0a. |
| 35219596 | Background | Davey MS, Davey MG, Hurley ET, Kearns SR. Tourniquet Use During Open Reduction and Internal Fixation of Ankle Fractures - A Systematic Review and Meta-Analysis. J Foot Ankle Surg. 2022 Sep-Oct;61(5):1103-1108. doi: 10.1053/j.jfas.2022.01.019. Epub 2022 Jan 23. |
| 25979462 | Background | Kruse H, Christensen KP, Moller AM, Gogenur I. Tourniquet use during ankle surgery leads to increased postoperative opioid use. J Clin Anesth. 2015 Aug;27(5):380-4. doi: 10.1016/j.jclinane.2015.03.034. Epub 2015 May 12. |
| 15766423 | Background | Younger AS, Kalla TP, McEwen JA, Inkpen K. Survey of tourniquet use in orthopaedic foot and ankle surgery. Foot Ankle Int. 2005 Mar;26(3):208-17. doi: 10.1177/107110070502600305. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |