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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

sepsis

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tourniquet

    Procedure/Surgery

    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.

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: TourniquetActive comparator 1 intervention
Group B: No TourniquetNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Collected preoperatively and 12 weeks postoperatively
2

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.

Time frame
Collected preoperatively and 12 weeks postoperatively
3

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).

Time frame
Collected preoperatively and 12 weeks postoperatively

Secondary outcomes

1

Pain Score

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
2

Malleolar circumference

bilateral malleolar circumference in cm will be measured by blinded physical therapists

Time frame
Collected at 6 weeks and 12 weeks postoperatively
3

Calf girth

bilateral calf girth in cm will be measured by blinded physical therapists

Time frame
Collected at 6 weeks and 12 weeks postoperatively
4

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.

Time frame
Collected at 6 weeks and 12 weeks postoperatively

Other outcomes

Sponsors and contacts

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