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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; ERAS
• Interventions: Procedure: ERAS protocols for TKA

• Registration Number: NCT04873544
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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

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 Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Common protocols for TKA	ERAS protocols for TKA	Common protocols for TKA

Primary Outcome Measures

Name	Time	Method
the postoperative hospitalization time	12 months	the postoperative hospitalization time

Secondary Outcome Measures

Name	Time	Method
visual analogue scale score (VAS score)	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.
New York Hospital of Special Surgery knee score (HSS score)	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.
the operative time	2 hours	the operative time
first straight leg elevation time	1 day	first straight leg elevation time
knee range of motion	12 months	knee range of motion
first postoperative walking time	1 day	first postoperative walking time
Knee Society Score (KSS score)	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.

Trial Locations

Locations (1)

Nanjing first hospital; 🇨🇳 Nanjing, Jiangsu, China