The Effect of the Tourniquet in Bilateral Total Knee Replacement

NCT06228651 | Completed DMC

• 1 other identifier: s-20150100
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements

Conditions

Tourniquet and Outcome After Total Knee Replacement

Keywords

Tourniquet, Total knee replacement, Oxford knee score, Forgotten Joint Score

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Pain at rest evaluated at a visual analogue scale (VAS)

  2 weeks postoperatively

Secondary Outcomes (2)

• Forgotten Joint Score (FJS) and Oxford Knee Score (OKS)

  two weeks, four weeks, three months and one year postop

• Wound complications and deep vein thrombosis and re-admissions

  within one year postop

Study Arms (2)

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

Tourniquet DEVICE

Tourniquet

The leg without the tourniquet OTHER

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

MeSH Terms

Interventions

Tourniquets

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: March 14, 2016
• Primary Completion: March 1, 2021
• Study Completion: December 21, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share