Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tourniquet.
- Who it may be relevant to
- Registry conditions: Ankle Fractures, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Tourniquet
This arm will have a tourniquet placed about the thigh and inflated to 250mmHg for the duration of ankle fracture surgery or 2 hours, whichever is shorter.
Primary outcome measures
- Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks [Time frame: Collected preoperatively and 12 weeks postoperatively]
- Change from Baseline Patient-Reported Outcomes Measurement Information System Pain Interference Subscale at 12 weeks [Time frame: Collected preoperatively and 12 weeks postoperatively]
- Change from Baseline Foot and Ankle Ability Measure at 12 weeks [Time frame: Collected preoperatively and 12 weeks postoperatively]
Secondary outcome measures (10)
- Pain Score [Time frame: Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively]
- Malleolar circumference [Time frame: Collected at 6 weeks and 12 weeks postoperatively]
- Calf girth [Time frame: Collected at 6 weeks and 12 weeks postoperatively]
- Mobility [Time frame: Collected at 6 weeks and 12 weeks postoperatively]
- Ankle range of motion [Time frame: Collected at 6 weeks and 12 weeks postoperatively]
- Fatigability [Time frame: Collected at 6 weeks and 12 weeks postoperatively]
- Proximal and distal lower extremity strength [Time frame: Collected at 6 weeks and 12 weeks postoperatively]
- Single-limb stance time [Time frame: Collected at 6 weeks and 12 weeks postoperatively]
- Y-balance test scores [Time frame: Collected at 6 weeks and 12 weeks postoperatively]
- Limb pH [Time frame: Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oregon Health and Science University — Portland
Publications
- 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. PMID 9429882
- 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. PMID 15805957
- 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. PMID 15766423
- 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. PMID 30282469
- Wilgis EF. Observations on the effects of tourniquet ischemia. J Bone Joint Surg Am. 1971 Oct;53(7):1343-6. No abstract available. PMID 5114697
- Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.
Identifiers
NCT: NCT05445960 · STUDY00022560