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

Primary Purpose

Ankle Fractures, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tourniquet
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Oregon Health and Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Tourniquet

No Tourniquet

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Pain Score
Patients will score their pain on a Visual Analog pain scale (VAS) (0-10)
Malleolar circumference
bilateral malleolar circumference in cm will be measured by blinded physical therapists
Calf girth
bilateral calf girth in cm will be measured by blinded physical therapists
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.
Ankle range of motion
ankle range of motion (flexion, extension, inversion, eversion) will be measured in degrees with goniometer by blinded physical therapists
Fatigability
Utilizing a biodex machine, fatigability or total work in foot pounds, will be measured by blinded physical therapists
Proximal and distal lower extremity strength
proximal and distal lower extremity strength, via handheld dynamometer, in lb will be measured by blinded physical therapists
Single-limb stance time
Single-limb stance time (seconds) will be measured by blinded physical therapists
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.
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

Full Information

First Posted
May 10, 2022
Last Updated
June 30, 2022
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05445960
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
August 17, 2024 (Anticipated)
Study Completion Date
August 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar, Ankle Fracture - Medial Malleolus, Maisonneuve's Fracture, Syndesmotic Injuries, Fibula Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tourniquet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Tourniquet
Arm Type
No Intervention
Arm Description
This arm will have a tourniquet placed around the thigh but NOT inflated for the duration of ankle fracture surgery.
Intervention Type
Procedure
Intervention Name(s)
Tourniquet
Intervention Description
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 Measure Information:
Title
Patient-Reported Outcomes Measurement Information System Physical Function Subscale
Description
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
Time Frame
Collected preoperatively and at 3 week, 6 week and 12 week postoperatively
Title
Patient-Reported Outcomes Measurement Information System Pain Interference Subscale
Description
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
Time Frame
Collected preoperatively and at 3 week, 6 week and 12 week postoperatively
Title
Foot and Ankle Ability Measure
Description
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
Time Frame
Collected preoperatively and at 3 week, 6 week and 12 week postoperatively
Secondary Outcome Measure Information:
Title
Pain Score
Description
Patients will score their pain on a Visual Analog pain scale (VAS) (0-10)
Time Frame
Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively
Title
Malleolar circumference
Description
bilateral malleolar circumference in cm will be measured by blinded physical therapists
Time Frame
Collected at 6 weeks and 12 weeks postoperatively
Title
Calf girth
Description
bilateral calf girth in cm will be measured by blinded physical therapists
Time Frame
Collected at 6 weeks and 12 weeks postoperatively
Title
Mobility
Description
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.
Time Frame
Collected at 6 weeks and 12 weeks postoperatively
Title
Ankle range of motion
Description
ankle range of motion (flexion, extension, inversion, eversion) will be measured in degrees with goniometer by blinded physical therapists
Time Frame
Collected at 6 weeks and 12 weeks postoperatively
Title
Fatigability
Description
Utilizing a biodex machine, fatigability or total work in foot pounds, will be measured by blinded physical therapists
Time Frame
Collected at 6 weeks and 12 weeks postoperatively
Title
Proximal and distal lower extremity strength
Description
proximal and distal lower extremity strength, via handheld dynamometer, in lb will be measured by blinded physical therapists
Time Frame
Collected at 6 weeks and 12 weeks postoperatively
Title
Single-limb stance time
Description
Single-limb stance time (seconds) will be measured by blinded physical therapists
Time Frame
Collected at 6 weeks and 12 weeks postoperatively
Title
Y-balance test scores
Description
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.
Time Frame
Collected at 6 weeks and 12 weeks postoperatively
Title
Limb pH
Description
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
Time Frame
Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Atwater, MD
Phone
5034946400
Email
atwaterl@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Atwater, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Atwater, MD
Phone
503-494-6400
Email
atwaterl@ohsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9429882
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.
Results Reference
background
PubMed Identifier
15805957
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.
Results Reference
background
PubMed Identifier
15766423
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.
Results Reference
background
PubMed Identifier
30282469
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.
Results Reference
background
PubMed Identifier
5114697
Citation
Wilgis EF. Observations on the effects of tourniquet ischemia. J Bone Joint Surg Am. 1971 Oct;53(7):1343-6. No abstract available.
Results Reference
background
Citation
Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.
Results Reference
background

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

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