ERASNCT04873544
Enhanced Recovery After Surgery Protocols in Total Knee Arthroplasty Via Midvastus Approach
A study testing ERAS protocols for TKA in people with ERAS and Knee Osteoarthritis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 56 to 74 years
- Conditions the study is for
- ERAS, Knee Osteoarthritis
- What is being tested?
- ERAS protocols for TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- ERAS, Knee Osteoarthritis
- Being tested
- ERAS protocols for TKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocols for TKAProcedure or surgery
ERAS protocols for TKA
| Study group | Role | What they receive |
|---|---|---|
| Common protocols for TKA | Experimental | Common protocols for TKA Receives: Procedure: ERAS protocols for TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
the postoperative hospitalization time
the postoperative hospitalization time
Measured: 12 months
Secondary outcomes (7)
the operative time
the operative time
Measured: 2 hours
first postoperative walking time
first postoperative walking time
Measured: 1 day
first straight leg elevation time
first straight leg elevation time
Measured: 1 day
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
knee range of motion
knee range of motion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873544
- Sponsor's protocol ID
- KY20170418-02
- Status last verified
- Jul 2020
- First submitted
- 30 Apr 2021
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34625057
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Protocols in Total Knee Arthroplasty Via Midvastus Approach
- ClinicalTrials.gov ID
- NCT04873544
- Acronym / sponsor ID
- KY20170418-02
- Conditions
- ERAS, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Common protocols for TKA | Experimental | Procedure: ERAS protocols for TKACommon protocols for TKA |
Who may qualify
- Ages
- 56 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Rheumatoid arthritis
- Extra-knee deformity
- Simultaneous bilateral knee arthroplasty
- Severe dysfunction of the liver, kidney, and blood system
- Severe cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS protocols for TKAERAS protocols for TKA | Procedure or surgery | Common protocols for TKA |
Primary outcome
the postoperative hospitalization time
Time frame: 12 months
the postoperative hospitalization time
7 secondary outcomes
the operative time
Time frame: 2 hours
first postoperative walking time
Time frame: 1 day
first straight leg elevation time
Time frame: 1 day
visual analogue scale score (VAS score)
Time frame: 12 months
New York Hospital of Special Surgery knee score (HSS score)
Time frame: 12 months
Knee Society Score (KSS score)
Time frame: 12 months
knee range of motion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Derived from this study: PubMed 34625057Wei 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocols for TKA in people with ERAS and Knee Osteoarthritis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the postoperative hospitalization time (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04873544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.