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Completed

NCT Number: NCT04873544

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

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

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Key information

Age range

56 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing first hospital

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERAS protocols for TKA

Procedure

ERAS protocols for TKA

Primary outcomes

  1. the postoperative hospitalization time

    Time frame: 12 months

    the postoperative hospitalization time

Secondary outcomes

  1. the operative time

    Time frame: 2 hours

    the operative time

  2. first postoperative walking time

    Time frame: 1 day

    first postoperative walking time

  3. first straight leg elevation time

    Time frame: 1 day

    first straight leg elevation time

  4. 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.

  5. 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.

  6. 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.

  7. knee range of motion

    Time frame: 12 months

    knee range of motion

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 5, 2021
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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