Enhanced Recovery After Surgery Protocols in Total Knee Arthroplasty Via Midvastus Approach
Primary Purpose
ERAS, Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ERAS protocols for TKA
Sponsored by
About this trial
This is an interventional treatment trial for ERAS
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.
Sites / Locations
- Nanjing first hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Common protocols for TKA
Arm Description
Common protocols for TKA
Outcomes
Primary Outcome Measures
the postoperative hospitalization time
the postoperative hospitalization time
Secondary Outcome Measures
the operative time
the operative time
first postoperative walking time
first postoperative walking time
first straight leg elevation time
first straight leg elevation time
visual analogue scale score (VAS score)
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.
New York Hospital of Special Surgery knee score (HSS score)
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.
Knee Society Score (KSS score)
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.
knee range of motion
knee range of motion
Full Information
NCT ID
NCT04873544
First Posted
April 30, 2021
Last Updated
May 5, 2021
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04873544
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ERAS, Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Common protocols for TKA
Arm Type
Experimental
Arm Description
Common protocols for TKA
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols for TKA
Intervention Description
ERAS protocols for TKA
Primary Outcome Measure Information:
Title
the postoperative hospitalization time
Description
the postoperative hospitalization time
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the operative time
Description
the operative time
Time Frame
2 hours
Title
first postoperative walking time
Description
first postoperative walking time
Time Frame
1 day
Title
first straight leg elevation time
Description
first straight leg elevation time
Time Frame
1 day
Title
visual analogue scale score (VAS score)
Description
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.
Time Frame
12 months
Title
New York Hospital of Special Surgery knee score (HSS score)
Description
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.
Time Frame
12 months
Title
Knee Society Score (KSS score)
Description
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.
Time Frame
12 months
Title
knee range of motion
Description
knee range of motion
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Nanjing first hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34625057
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.
Results Reference
derived
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Enhanced Recovery After Surgery Protocols in Total Knee Arthroplasty Via Midvastus Approach
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