Trials / Completed
CompletedNCT06228651
The Effect of the Tourniquet in Bilateral Total Knee Replacement
The Functional Outcome of the Arterial Tourniquet in Total Knee Arthroplasty- a RCT of Bilateral Total Knee Arthroplasties.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Odense University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements
Detailed description
Background: Tourniquet application during total knee arthroplasty (TKA) is a common practice aimed at reducing intraoperative bleeding. However, concerns have been raised about potential tissue damage from ischemia and reperfusion injury. Objectives: This study examines the effects of tourniquet use during TKA on postoperative functional outcomes, including pain, range of motion (ROM), and patient-reported outcomes (PROMs). Methods: In a fast-track surgical setting, a prospective, randomized, double-blinded trial was conducted with patients undergoing bilateral TKA. Tourniquets were applied to one knee, while the contralateral knee served as a control. Evaluations were conducted at two and four weeks, and at three and twelve months postoperatively, employing paired t-tests and mixed-effects linear modeling for data analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tourniquet | |
| OTHER | The leg without the tourniquet |
Timeline
- Start date
- 2016-03-14
- Primary completion
- 2021-03-01
- Completion
- 2023-12-21
- First posted
- 2024-01-29
- Last updated
- 2024-01-29
Source: ClinicalTrials.gov record NCT06228651. Inclusion in this directory is not an endorsement.