Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery

NCT05445960 | Recruiting

• 1 other identifier: STUDY00022560
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures; Ankle Fracture - Lateral Malleolus; Ankle Fracture, Bimalleolar; Ankle Fracture, Trimalleolar; Ankle Fracture - Medial Malleolus; Maisonneuve's Fracture; Syndesmotic Injuries; Fibula Fracture

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks

  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. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). A score of 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For example a score of 40 is one SD lower than the mean of the reference population where as a score of 60 is one SD higher than the mean of the reference population. Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

  Collected preoperatively and 12 weeks postoperatively

• Change from Baseline Patient-Reported Outcomes Measurement Information System Pain Interference Subscale at 12 weeks

  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. A score of 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For example a score of 40 is one SD lower than the mean of the reference population where as a score of 60 is one SD higher than the mean of the reference population. Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

  Collected preoperatively and 12 weeks postoperatively

• Change from Baseline Foot and Ankle Ability Measure at 12 weeks

  Foot and Ankle Ability Measure (FAAM), a Patient Reported Outcome survey used widely in orthopaedic Foot and Ankle literature, will be obtained and reported in points. Scores range from 0% (least function) to 100% (most function).

  Collected preoperatively and 12 weeks postoperatively

Secondary Outcomes (10)

• Pain Score

  Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively

• Malleolar circumference

  Collected at 6 weeks and 12 weeks postoperatively

• Calf girth

  Collected at 6 weeks and 12 weeks postoperatively

• Mobility

  Collected at 6 weeks and 12 weeks postoperatively

• Ankle range of motion

  Collected at 6 weeks and 12 weeks postoperatively

Study Arms (2)

Tourniquet

ACTIVE COMPARATOR

This arm will have a tourniquet placed around the thigh inflated to 250mmHg for the duration of surgery (until splint placed) or 2 hours, whichever is shorter, during ankle fracture surgery.

Procedure: Tourniquet

No Tourniquet

NO INTERVENTION

This arm will have a tourniquet placed around the thigh but NOT inflated for the duration of ankle fracture surgery.

Interventions

Tourniquet PROCEDURE

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.

Tourniquet

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (6)

• 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 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.

  PMID: 15805957 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.

  PMID: 15766423 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.

  BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Fibula Fractures; Ankle Injuries

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Lara Atwater, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Atwater, MD

CONTACT

5034946400; atwaterl@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: July 6, 2022
• Study Start: August 17, 2021
• Primary Completion: March 17, 2026
• Study Completion (Estimated): March 17, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)