Tourniquet Pressure in Primary Total Knee Arthroplasty
Stopped early · Not applicable
Conditions studied: Tourniquets, Knee Arthroplasty, Total, Knee Replacement, Total
In brief
This proposed novel randomized control trial (RCT) seeks to address this gap in TKA protocol by gaining a better understanding of the relationship between tourniquet pressure and time, and intraoperative performance and post-operative outcomes. This study does not seek to answer the question of "tourniquet vs no tourniquet", but to seek a tourniquet usage that would maximize the intraoperative benefits for the surgeon and minimize the negative consequences for patient outcomes. Specific Aim #1: enroll around 146 primary TKA patients. Specific Aim #2: evaluate different tourniquet cuff pressures (TCP) and tourniquet times in relation to intraoperative performance. Specific Aim #3: evaluate different TCP and tourniquet times in relation to post-operative pain and complications of short-term, intermediate, and long-term followup. Specific Aim #4: evaluate different TCP and tourniquet times in relation to post-operative function of short-term, intermediate, and long-term followup.
Key facts
- Study ID
- NCT02830087
- Run by
- Wake Forest University Health Sciences
- People needed
- 21
- Starts
- 2016-06-01
- Expected to finish
- 2016-09-20
- Last updated by the study team
- 2018-12-19
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 - 80 years old
- primary TKA, not revision
You may not qualify if…
- systolic blood pressure (BP) ≥ 170 mmHg
- one-staged bilateral TKA or stages less than three months apart
- history of peripheral vascular disease
- history of thromboembolism
Where it is running
- Davie Medical Center — Bermuda Run, North Carolina, United States
- Wake Forest Baptist Hospital — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.