NCT04084912

Brief Summary

Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative:

  1. 1.pain
  2. 2.oedema
  3. 3.nausea and vomiting
  4. 4.quadriceps power
  5. 5.knee flexion
  6. 6.wound complications

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2020

Status
unknown

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

First Submitted

Initial submission to the registry

September 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

September 5, 2019

Last Update Submit

December 19, 2019

Conditions

Arthropathy of Knee

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain summarized in the first 14 days

    postoperative pain summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery pain is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no pain and 100 is the worst pain one can imagine Moderate pain is considered a VAS \>30 mm.

    14 days

Secondary Outcomes (4)

  • Postoperative Thigh circumference in the first 14 days

    14 days

  • postoperative nausea and vomiting in the first 14 days

    14 days

  • postoperative knee flexion in the first 14 days

    14 days

  • Surgical wound infection in the first 14 days

    14 days

Study Arms (2)

Dexamethasone group

ACTIVE COMPARATOR

this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision

Drug: Dexamethasone Sodium Phosphate

Placebo group

PLACEBO COMPARATOR

this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision

Drug: Saline Solution

Interventions

Dexamethasone Sodium PhosphateDRUG

intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg

Also known as: Steroid
Dexamethasone group
Saline SolutionDRUG

intravenous injection of one ampoule saline

Also known as: saline
Placebo group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient scheduled for primary total knee replacement arthroplasty

You may not qualify if:

  • Diabetic patients
  • Rheumatoid arthritis patients
  • Patients on regular steroid therapy
  • Patients refused to be enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Xing LZ, Li L, Zhang LJ. Can intravenous steroid administration reduce postoperative pain scores following total knee arthroplasty?: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(24):e7134. doi: 10.1097/MD.0000000000007134.

    PMID: 28614237BACKGROUND

  • Rytter S, Stilling M, Munk S, Hansen TB. Methylprednisolone reduces pain and decreases knee swelling in the first 24 h after fast-track unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):284-290. doi: 10.1007/s00167-014-3501-8. Epub 2015 Jan 7.

    PMID: 25564196BACKGROUND

  • Fan Z, Ma J, Kuang M, Zhang L, Han B, Yang B, Wang Y, Ma X. The efficacy of dexamethasone reducing postoperative pain and emesis after total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:149-155. doi: 10.1016/j.ijsu.2018.02.043. Epub 2018 Feb 23.

    PMID: 29481989BACKGROUND

  • Meng J, Li L. The efficiency and safety of dexamethasone for pain control in total joint arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Jun;96(24):e7126. doi: 10.1097/MD.0000000000007126.

    PMID: 28614232BACKGROUND

  • Yue C, Wei R, Liu Y. Perioperative systemic steroid for rapid recovery in total knee and hip arthroplasty: a systematic review and meta-analysis of randomized trials. J Orthop Surg Res. 2017 Jun 27;12(1):100. doi: 10.1186/s13018-017-0601-4.

    PMID: 28655354BACKGROUND

MeSH Terms

Interventions

dexamethasone 21-phosphateSteroidsSaline SolutionSodium Chloride

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Hatem Bakr, asst. prof

    Assiut University

    STUDY CHAIR

Central Study Contacts

David Nady, physician

CONTACT

+2001203649367david011183@med.au.edu.eg

mohammed abdelnasser, Doctor

CONTACT

+2001002438664abdelnasser.m.k@med.au.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 10, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

June 1, 2021

Last Updated

December 23, 2019

Record last verified: 2019-12