Clinical trial NCT04873544: Enhanced Recovery After Surgery Protocols in Total Knee Arthroplasty Via Midvastus Approach
Official title: Enhanced Recovery After Surgery Protocols in Total Knee Arthroplasty Via Midvastus Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ERAS
Knee Osteoarthritis
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 69
Sex: ALL
Minimum age (years): 56
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the postoperative hospitalization time
timeFrame: 12 months
Secondary outcomes:
measure: the operative time
timeFrame: 2 hours
measure: first postoperative walking time
timeFrame: 1 day
measure: first straight leg elevation time
timeFrame: 1 day
measure: visual analogue scale score (VAS score)
timeFrame: 12 months
measure: New York Hospital of Special Surgery knee score (HSS score)
timeFrame: 12 months
measure: Knee Society Score (KSS score)
timeFrame: 12 months
measure: knee range of motion
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing first hospital
state: Jiangsu
Study officials:
References:
citation: Wei B, Tang C, Li X, Lin R, Han L, Zheng S, Xu Y, Yao Q, Wang L. Enhanced recovery after surgery protocols in total knee arthroplasty via midvastus approach: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Oct 8;22(1):856. doi: 10.1186/s12891-021-04731-6.