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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873544
• Other study ID #: KY20170418-02
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 56 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• ERAS
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• ERAS protocols for TKA
ERAS protocols for TKA

Locations

Country	Name	City	State
China	Nanjing first hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the postoperative hospitalization time	the postoperative hospitalization time	12 months
Secondary	the operative time	the operative time	2 hours
Secondary	first postoperative walking time	first postoperative walking time	1 day
Secondary	first straight leg elevation time	first straight leg elevation time	1 day
Secondary	visual analogue scale score (VAS score)	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
Secondary	New York Hospital of Special Surgery knee score (HSS score)	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
Secondary	Knee Society Score (KSS score)	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
Secondary	knee range of motion	knee range of motion	12 months