NCT04873544

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
Last Updated

May 10, 2021

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

April 30, 2021

Last Update Submit

May 5, 2021

Conditions

ERASKnee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • the postoperative hospitalization time

    the postoperative hospitalization time

    12 months

Secondary Outcomes (7)

  • the operative time

    2 hours

  • first postoperative walking time

    1 day

  • first straight leg elevation time

    1 day

  • visual analogue scale score (VAS score)

    12 months

  • New York Hospital of Special Surgery knee score (HSS score)

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Common protocols for TKA

EXPERIMENTAL

Common protocols for TKA

Procedure: ERAS protocols for TKA

Interventions

ERAS protocols for TKAPROCEDURE

ERAS protocols for TKA

Common protocols for TKA

Eligibility Criteria

Age56 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing first hospital

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

  • 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.

    PMID: 34625057DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 5, 2021

Study Start

October 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2020

Last Updated

May 10, 2021

Record last verified: 2020-07

Locations

CN(1)