Enhanced Recovery After Surgery Protocols in Total Knee Arthroplasty Via Midvastus Approach

May 5, 2021 updated by: Nanjing First Hospital, Nanjing Medical University
The study aimed to investigate the impact of enhanced recovery after surgery (ERAS) protocols on the clinical effect of total knee arthroplasty (TKA) via the midvastus approach

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, a randomized controlled study was conducted to further investigate the impact of ERAS protocols in the clinical efficacy of TKA with the midvastus approach. The ERAS protocols were adopted for the ERAS group and consisted of pure juice drinking 2 hours before the surgery, optimization of the preoperative anesthesia plan, phased use of tourniquets, and the use of tranexamic acid as well as a drug cocktail. The operative time, first postoperative walking time, first straight leg elevation time, postoperative hospitalization time, visual analogue scale score (VAS score), New York Hospital of Special Surgery knee score (HSS score), Knee Society Score (KSS score), and knee range of motion were used to assess the clinical effects in the two groups. All the included patients were followed up for 12 months.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral primary knee osteoarthritis
  • Varus, valgus, and flexion contracture deformity of the knee joint < 10°
  • The range of motion of the knee joint was > 80°
  • Body mass index (BMI) < 30
  • No previous history of knee surgery on the affected side .Agreed to participate in the trial.

Exclusion Criteria:

  • Rheumatoid arthritis
  • Extra-knee deformity
  • Simultaneous bilateral knee arthroplasty
  • Severe dysfunction of the liver, kidney, and blood system
  • Severe cardiovascular diseases
  • Gastrointestinal ulcer .Other medical conditions like nausea, vomiting, snoring, and allergy to related analgesic drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Common protocols for TKA
Procedure: ERAS protocols for TKA
ERAS protocols for TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the postoperative hospitalization time
Time Frame: 12 months
the postoperative hospitalization time
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the operative time
Time Frame: 2 hours
the operative time
2 hours
first postoperative walking time
Time Frame: 1 day
first postoperative walking time
1 day
first straight leg elevation time
Time Frame: 1 day
first straight leg elevation time
1 day
visual analogue scale score (VAS score)
Time Frame: 12 months
VAS score (0-10 scores) is for pain: 0 represent no pain, 1-3 represent mild pain, 4-6 represent moderate pain, 7-10 represent severe pain.
12 months
New York Hospital of Special Surgery knee score (HSS score)
Time Frame: 12 months
HSS score (0-100 scores) is for knee function: 85-100 represent excellent, 70-84 represent good, 60-69 represent fair, 0-59 represent bad.
12 months
Knee Society Score (KSS score)
Time Frame: 12 months
KSS score (0-100 scores) is for knee function: 85-100 represent excellent, 70-84 represent good, 60-69 represent fair, 0-59 represent bad.
12 months
knee range of motion
Time Frame: 12 months
knee range of motion
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20170418-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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