NCT04486040

Brief Summary

Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided in to two groups with or without drainage. All patients was assessed with ultrasonography on 3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed after surgery. Patients was assessed with Harris Hips Score and Visual Analog Scale after surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

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

March 14, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

July 22, 2020

Last Update Submit

August 2, 2021

Conditions

Hip OsteoarthritisBleeding

Keywords

HipRevisionArthroplastyDrainage

Outcome Measures

Primary Outcomes (4)

  • Hematoma size

    Level of fluid at endoprosthesis neck in ultrasonography

    3 days after surgery

  • Hemoglobin level

    Hemoglobin level after surgery on 1st and 3rd day after surgery

    3 days after surgery

  • Blood loss

    Assessing blood loss with use of Gross formula

    1 day after surgery

  • Reinfection

    Number of patients with infection after surgery performed in the study

    2 years after surgery

Secondary Outcomes (5)

  • Soft tissue hematoma

    3 days after surgery

  • C-reactive protein level

    3 days after surgery

  • Blood transfusion

    5-14 days after surgery

  • Visual Analog Scale

    3 days after surgery

  • Harris Hip Score

    6 weeks after surgery

Study Arms (2)

Drainage group

ACTIVE COMPARATOR

Patients with drainage after hip revision arthroplasty

Procedure: Drainage

No-drainage group

ACTIVE COMPARATOR

Patients without drainage after hip revision arthroplasty

Procedure: No-drainage

Interventions

DrainagePROCEDURE

Use of the suction drainage after hip revision arthroplasty

Drainage group
No-drainagePROCEDURE

Patients without drainage after surgery

No-drainage group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aseptic loosening,
  • head or insert damage,
  • girdlestone hip

You may not qualify if:

  • septic loosening,
  • primary or secondary coagulopathy,
  • renal or hepatic failure,
  • thromboembolism in past history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, HipHemorrhage

Interventions

Drainage

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Officials

  • Pawel Bartosz

    Gruca Teaching Hospital, Centre of Postgraduate Medical Education in Otwock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D. Principal Investigator

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

March 14, 2016

Primary Completion

March 13, 2018

Study Completion

March 13, 2020

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share