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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04873544
Enrollment
69
Registered
2021-05-05
Start date
2018-10-01
Completion date
2020-06-30
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ERAS, Knee Osteoarthritis

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.

Interventions

PROCEDUREERAS protocols for TKA

ERAS protocols for TKA

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
56 Years to 74 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the postoperative hospitalization time12 monthsthe postoperative hospitalization time

Secondary

MeasureTime frameDescription
first straight leg elevation time1 dayfirst straight leg elevation time
the operative time2 hoursthe operative time
first postoperative walking time1 dayfirst postoperative walking time
visual analogue scale score (VAS score)12 monthsVAS 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.
Knee Society Score (KSS score)12 monthsKSS score (0-100 scores) is for knee function: 85-100 represent excellent, 70-84 represent good, 60-69 represent fair, 0-59 represent bad.
knee range of motion12 monthsknee range of motion
New York Hospital of Special Surgery knee score (HSS score)12 monthsHSS score (0-100 scores) is for knee function: 85-100 represent excellent, 70-84 represent good, 60-69 represent fair, 0-59 represent bad.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026