Does Tourniquet Use Have an Effect on Pain and Function After Total Knee Arthroplasty

NCT04733716 | Completed

• 1 other identifier: 2020/13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA) is an effective surgical procedure for reducing knee joint pain and improving the quality of life of patients with advanced knee osteoarthritis. Although advanced surgical techniques and prosthesis design are achieved, postoperative pain is a significant factor that affects those patients who have undergone TKA with a satisfactory outcome. The reasons for postoperative pain after TKA are somewhat unclear Although there are studies evaluating the preoperative and postoperative conditions of the patients using pain scores, these values differ greatly in patients who are suitable for the same procedure. Previous studies have demonstrated that variability exists between individuals in basal pain sensitivity, which is assessed using quantitative sensory testing To our knowledge, only one study has investigated the pain condition using an algometer and postoperative pain and the analgesic requirement on the day of surgery and during the postoperative period.Unlike the above-cited study, in this study, we evaluated the effect of using a tourniquet on early-stage pain and 1-year postoperative functional outcomes when patients were divided into two groups according to the pain threshold.

Conditions

Arthropathy of Knee; Pain, Joint

Keywords

Knee Arthroplasty

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale Outcome-1

  Both groups were also evaluated with Visual Analog Scale for assess the pain status postoperatively.

  24 hour

• Visual Analog Scale Outcome-2

  Both groups were also evaluated with Visual Analog Scale for assess the pain status postoperatively.

  36 hour

• Visual Analog Scale Outcome-3

  Both groups were also evaluated with Visual Analog Scale for assess the pain status postoperatively.

  48 hour

• Knee Society Score

  The Knee society score (KSS) consists of two parts. One part is the knee score (KSS1), which includes pain (maximum 50 points), stability, total range of flexion, and other items (varus, valgus, extension delay, and flexion contracture). The other part (KSS2) is the function score, which has two components, walking capacity and stair-climbing ability and deductions done if the patient using any assistive devices.

  First year

Study Arms (2)

Total Knee Arthroplasty with using Tourniquet

ACTIVE COMPARATOR

A pneumatic tourniquet was used before surgery at the proximal thigh and inflated before the skin incision until skin closure in this group. The tourniquet was inflated to either 275 or 325 mmHg, depending on the patient's systolic blood pressure.

Procedure: Using Tourniquet

Total Knee Arthroplasty without using Tourniquet

ACTIVE COMPARATOR

A pneumatic tourniquet was not used in this group during the total knee arthroplasty.

Procedure: Using Tourniquet

Interventions

Using Tourniquet PROCEDURE

The purpose of this prospective randomized double blinded study was to compare the effect of using a tourniquet on early-stage pain and 1-year postoperative functional outcomes when patients were divided into two groups according to the pain threshold.

Total Knee Arthroplasty with using Tourniquet; Total Knee Arthroplasty without using Tourniquet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary knee osteoarthritis
• older than 18 years
• primary knee arthroplasty

You may not qualify if:

• Patients with a neurological disorder,
• diagnosed with fibromyalgia,
• history of knee operation,
• valgus knee,
• greater than 30° flexion contracture
• undergone bilateral knee arthroplasty or revision knee arthroplasty,
• chronic analgesic users, a
• patient with psychiatric disease

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Training and Research Hospital

Istanbul, Umraniye, 34760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The pain sensitivity of all measurement patients was taken on the day before the surgery by the same author, and these values were blinded from another author who recorded the repetitive postoperative VAS and knee scores.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 2, 2021
• Study Start: June 15, 2019
• Primary Completion: December 10, 2020
• Study Completion: January 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)