Clinical trial NCT05445960: Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
Official title: Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Fractures
Ankle Fracture - Lateral Malleolus
Ankle Fracture, Bimalleolar
Ankle Fracture, Trimalleolar
Ankle Fracture - Medial Malleolus
Maisonneuve's Fracture
Syndesmotic Injuries
Fibula Fracture
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to 1) characterize skeletal muscle pH during/after tourniquet use and 2) investigate any relationship between intraoperative tourniquet use and postoperative functional measures and patient-reported outcomes.

Detailed description: Tourniquets are widely accepted as "safe" for up to two hours of continued use, despite known risks and a paucity of literature supporting this duration. Complications of tourniquets include tourniquet site pain, increased surgical site pain and swelling from reperfusion, neuropraxia, vascular injury, functional weakness, and decreased muscle endurance. Similar to compartment syndrome, tourniquets eliminate the tissue perfusion gradient necessary for oxygen, glucose, and lactic acid exchange. Lack of molecular exchange within the tissue is thought to result in tissue anoxia and acidosis, leading to cellular death of skeletal muscle and nerves. This study randomizes patients undergoing ankle fracture surgery to tourniquet or no-tourniquet arms and studies outcomes including continuous intramuscular pH during and after surgery, and patient-reported outcomes and functional measures up to 3 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at OHSU

Exclusion Criteria:

* sepsis
* other significant long bone or internal injuries (including ipsilateral limb injuries).

Primary outcomes:
measure: Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks
timeFrame: Collected preoperatively and 12 weeks postoperatively
measure: Change from Baseline Patient-Reported Outcomes Measurement Information System Pain Interference Subscale at 12 weeks
timeFrame: Collected preoperatively and 12 weeks postoperatively
measure: Change from Baseline Foot and Ankle Ability Measure at 12 weeks
timeFrame: Collected preoperatively and 12 weeks postoperatively
Secondary outcomes:
measure: Pain Score
timeFrame: Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively
measure: Malleolar circumference
timeFrame: Collected at 6 weeks and 12 weeks postoperatively
measure: Calf girth
timeFrame: Collected at 6 weeks and 12 weeks postoperatively
measure: Mobility
timeFrame: Collected at 6 weeks and 12 weeks postoperatively
measure: Ankle range of motion
timeFrame: Collected at 6 weeks and 12 weeks postoperatively
measure: Fatigability
timeFrame: Collected at 6 weeks and 12 weeks postoperatively
measure: Proximal and distal lower extremity strength
timeFrame: Collected at 6 weeks and 12 weeks postoperatively
measure: Single-limb stance time
timeFrame: Collected at 6 weeks and 12 weeks postoperatively
measure: Y-balance test scores
timeFrame: Collected at 6 weeks and 12 weeks postoperatively
measure: Limb pH
timeFrame: Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours postoperatively
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Lara Atwater, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omeroglu H, Gunel U, Bicimoglu A, Tabak AY, Ucaner A, Guney O. The relationship between the use of tourniquet and the intensity of postoperative pain in surgically treated malleolar fractures. Foot Ankle Int. 1997 Dec;18(12):798-802. doi: 10.1177/107110079701801208.
citation: 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.
citation: 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.
citation: Hung M, Baumhauer JF, Licari FW, Voss MW, Bounsanga J, Saltzman CL. PROMIS and FAAM Minimal Clinically Important Differences in Foot and Ankle Orthopedics. Foot Ankle Int. 2019 Jan;40(1):65-73. doi: 10.1177/1071100718800304. Epub 2018 Oct 4.
citation: Wilgis EF. Observations on the effects of tourniquet ischemia. J Bone Joint Surg Am. 1971 Oct;53(7):1343-6. No abstract available.
citation: Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.