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Clinical Trials/NCT04873544
NCT04873544
Completed
Not Applicable

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

Nanjing First Hospital, Nanjing Medical University1 site in 1 country69 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ERAS
Sponsor
Nanjing First Hospital, Nanjing Medical University
Enrollment
69
Locations
1
Primary Endpoint
the postoperative hospitalization time
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
June 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

the postoperative hospitalization time

Time Frame: 12 months

the postoperative hospitalization time

Secondary Outcomes

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

Study Sites (1)

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