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

NCT ID: NCT04873544

Last Updated: 2021-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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ERAS Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Common protocols for TKA

Common protocols for TKA

Group Type EXPERIMENTAL

ERAS protocols for TKA

Intervention Type PROCEDURE

ERAS protocols for TKA

Interventions

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ERAS protocols for TKA

ERAS protocols for TKA

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

56 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanjing first hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 34625057 (View on PubMed)

Other Identifiers

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KY20170418-02

Identifier Type: -

Identifier Source: org_study_id

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