Ankle Fractures Clinical Trial
Official title:
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
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.
Status | Recruiting |
Enrollment | 390 |
Est. completion date | August 17, 2024 |
Est. primary completion date | August 17, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health and Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.
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. — View Citation
Konrad G, Markmiller M, Lenich A, Mayr E, Rüter A. Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94. — View Citation
Omeroglu H, Günel U, Biçimoglu A, Tabak AY, Uçaner A, Güney 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. — View Citation
Wilgis EF. Observations on the effects of tourniquet ischemia. J Bone Joint Surg Am. 1971 Oct;53(7):1343-6. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-Reported Outcomes Measurement Information System Physical Function Subscale | Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) subscale, a Patient Reported Outcome survey used widely in orthopaedic literature, will be obtained and reported in points | Collected preoperatively and at 3 week, 6 week and 12 week postoperatively | |
Primary | Patient-Reported Outcomes Measurement Information System Pain Interference Subscale | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) subscale, a Patient Reported Outcome survey used widely in orthopaedic literature, will be obtained and reported in points | Collected preoperatively and at 3 week, 6 week and 12 week postoperatively | |
Primary | Foot and Ankle Ability Measure | Foot and Ankle Ability Measure, a Patient Reported Outcome survey used widely in orthopaedic Foot and Ankle literature, will be obtained and reported in points | Collected preoperatively and at 3 week, 6 week and 12 week postoperatively | |
Secondary | Pain Score | Patients will score their pain on a Visual Analog pain scale (VAS) (0-10) | Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively | |
Secondary | Malleolar circumference | bilateral malleolar circumference in cm will be measured by blinded physical therapists | Collected at 6 weeks and 12 weeks postoperatively | |
Secondary | Calf girth | bilateral calf girth in cm will be measured by blinded physical therapists | Collected at 6 weeks and 12 weeks postoperatively | |
Secondary | Mobility | Mobility, via timed up and go test in seconds, will be measured by blinded physical therapists. Patients will be seated in a chair and the time to rise, walk 10 feet, turn, walk back to the chair and sit down will be recorded in seconds. | Collected at 6 weeks and 12 weeks postoperatively | |
Secondary | Ankle range of motion | ankle range of motion (flexion, extension, inversion, eversion) will be measured in degrees with goniometer by blinded physical therapists | Collected at 6 weeks and 12 weeks postoperatively | |
Secondary | Fatigability | Utilizing a biodex machine, fatigability or total work in foot pounds, will be measured by blinded physical therapists | Collected at 6 weeks and 12 weeks postoperatively | |
Secondary | Proximal and distal lower extremity strength | proximal and distal lower extremity strength, via handheld dynamometer, in lb will be measured by blinded physical therapists | Collected at 6 weeks and 12 weeks postoperatively | |
Secondary | Single-limb stance time | Single-limb stance time (seconds) will be measured by blinded physical therapists | Collected at 6 weeks and 12 weeks postoperatively | |
Secondary | Y-balance test scores | Y-balance test composite score (%) will be measured by blinded physical therapists. For this test, the length of the extremity is measured and the patient reaches the extremity for the longest distance in three planes (anterior, posteriomedial, posterolateral) and the greatest distances achieved are recorded. The score is obtained by the sum of the greatest distances reached in each plane divided by 3x the limb length. | Collected at 6 weeks and 12 weeks postoperatively | |
Secondary | Limb pH | a VersaFlex® pH catheter from the Covidien pH monitoring kit will be placed in the anterior compartment of the operative leg via small incision and the Digitrapper® Recorder will measure and record continuous intramuscular pH | Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours postoperatively |
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