The Effect of the Tourniquet in Bilateral Total Knee Repl... | NCT06228651

Studies
The Effect of the Tourniquet in Bilateral Total Knee Replacement

NCT06228651

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Jan 29, 2024Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Tourniquet and Outcome After Total Knee Replacement

Interventions

Tourniquet
The leg without the tourniquet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2016Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Dec 21, 2023Actual

First Submitted Date

Jan 19, 2024

First Submission Date that Met QC Criteria

Jan 26, 2024

First Posted Date

Jan 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2024

Last Update Posted Date

Jan 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tourniquet	Active Comparator	The leg with the tourniquet which was inflated during surgery	Device: Tourniquet
Control	Active Comparator	The leg without the tourniquet which was not inflated during surgery	Other: The leg without the tourniquet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tourniquet	Device		Tourniquet
The leg without the tourniquet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain	Pain at rest evaluated at a visual analogue scale (VAS)	2 weeks postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Forgotten Joint Score (FJS) and Oxford Knee Score (OKS)	Patient reported outcome	two weeks, four weeks, three months and one year postop
Wound complications and deep vein thrombosis and re-admissions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older, planned for bilateral cemented primary TKA due to osteoarthritis during the same session. and showed a uniform degree of osteoarthritis determined by the Kellgren-Lawrence classification

Exclusion Criteria:

non-Danish speaking patients, unable to cooperate for VAS scoring, coagulation disorders, salicylate-induced asthma, severe thrombocytopenia, serious heart failure, severe liver failure, hypovolemia (any cause), dehydration, angioedema, bronchospasm, undergoing lithium treatment, suspected or manifest gastrointestinal bleeding, cerebrovascular bleeding, high postoperative bleeding risk or delayed hemostasis, hypersensitivity to adrenaline, sympathomimetics or excipients , hypertrophic or ischemic heart disease, undergoing dihydroergotamine treatment and thyrotoxicosis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D014111	Tourniquets

ID	Term
D004864	Equipment and Supplies

Intervention Model Description

We conducted a prospective, randomized, double -blinded trial including patients with simultaneously performed bilateral TKA in a fast-track setup at Lillebaelt Hospital - Vejle, Denmark. After randomization, tourniquet was inflated to only one knee facilitating direct comparison with patients acting as their own controls. Postoperative evaluations were performed at predetermined intervals. Patient reported outcomes were measured for the following year postoperative

Masking Info

Masking

Double

Masking Description

The protocol for tourniquet application during TKA began with encasing the patient's thigh in a stockinette sleeve, followed by the fitting of the tourniquet cuff which was connected to the Zimmer A.T.S 3000 tourniquet system. To ascertain the individualized optimal pressure, a pulse oximeter was momentarily placed on the patient's limb before the cuff was inflated. The tourniquet was used from the start of the incision and was released just prior to closure of the joint capsule to ensure optimal hemostasis during the final stages of the procedure.

Who Masked

ParticipantInvestigator