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Tourniquet Use for Ankle Fracture Surgery

N/A
Recruiting
Led By Lara Atwater, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at OHSU
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively
Awards & highlights
No Placebo-Only Group

Study Summary

This trial looks at the effects of using a tourniquet during surgery on muscle function and patient recovery afterwards.

Who is the study for?
Adults aged 18 to 89 who are having surgery for an ankle fracture at OHSU can join this trial. It's not for those with other major bone or internal injuries, including on the same limb, or people with sepsis.Check my eligibility
What is being tested?
The study is looking at how using a tourniquet during ankle surgery affects muscle pH levels and if there's any link between its use and how well patients recover functionally and what they report about their outcomes after surgery.See study design
What are the potential side effects?
While specific side effects aren't listed, tourniquets may cause discomfort, temporary numbness, swelling in the operated limb, or skin marks where applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 89 years old and having surgery for an ankle fracture at OHSU.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Foot and Ankle Ability Measure
Pain
Patient-Reported Outcomes Measurement Information System Physical Function Subscale
Secondary outcome measures
Ankle range of motion
Calf girth
Fatigability
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: TourniquetActive Control1 Intervention
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.
Group II: No TourniquetActive Control1 Intervention
This arm will have a tourniquet placed around the thigh but NOT inflated for the duration of ankle fracture surgery.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
963 Previous Clinical Trials
6,845,096 Total Patients Enrolled
Lara Atwater, MDPrincipal InvestigatorOregon Health and Science University

Media Library

Tourniquet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05445960 — N/A
Fibula Fracture Research Study Groups: Tourniquet, No Tourniquet
Fibula Fracture Clinical Trial 2023: Tourniquet Highlights & Side Effects. Trial Name: NCT05445960 — N/A
Tourniquet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05445960 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants comprise the maximum capacity of this experiment?

"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants; it was first advertised on August 17th 2021 and underwent an update the 30th of June 2022. This trial requires 390 people from one single location for its completion."

Answered by AI

Who can qualify to participate in this examination?

"This research is targeting 390 adults, aged 18 to 89, who have sustained ankle fractures. To be considered for participation in the trial, patients must meet these criteria: they must be undergoing surgical ankle fracture fixation at Oregon Health & Science University (OHSU)."

Answered by AI

What objectives is this experiment trying to accomplish?

"This clinical trial has the ultimate goal of evaluating Foot and Ankle Ability Measure over a three-month period. Secondary objectives encompass Pain Score, which is measured by Patients with a Visual Analog pain scale (VAS) (0-10), Proximal and distal lower extremity strength, assessed via handheld dynamometer in lb by blinded physical therapists, as well as Calf girth, evaluated through bilateral calf girth measurements in cm conducted by similarly blindfolded medical professionals."

Answered by AI

Do participants need to be of a certain age in order to participate in this experiment?

"According to the trial's terms, only individuals between 18-89 years old are eligible for participation. On the other hand, there are 69 studies available for participants aged below 18 and 308 trials specifically catered towards people 65 or older."

Answered by AI

Are there opportunities to join this testing program right now?

"According to clinicaltrials.gov, this ongoing research is currently in need of participants. The first announcement for the trial was made on August 17th 2021 and has since been updated last month (June 30th 2022)."

Answered by AI
Recent research and studies
~54 spots leftby Aug 2024