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Closed Suction Drainage After Revision Hip Arthroplasty

NCT ID: NCT04486040

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-14

Study Completion Date

2020-03-13

Brief Summary

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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.

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Detailed Description

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Inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. Exclusion criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure, thromboembolism in past history. At the end of operation information of drainage was get out from the envelope. On 3rd day all patient get ultrasonography with level of fluid in the joint and hematoma in soft tissue measurement. We analyzed hemoglobin, C-reactive protein, erythrocyte sedimentation rate on 1st and 3rd day after surgery. Visual analog scale was taken on 3rd day after surgery and Harris Hip Score 6 weeks after.

Conditions

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Hip Osteoarthritis Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drainage group

Patients with drainage after hip revision arthroplasty

Group Type ACTIVE_COMPARATOR

Drainage

Intervention Type PROCEDURE

Use of the suction drainage after hip revision arthroplasty

No-drainage group

Patients without drainage after hip revision arthroplasty

Group Type ACTIVE_COMPARATOR

No-drainage

Intervention Type PROCEDURE

Patients without drainage after surgery

Interventions

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Drainage

Use of the suction drainage after hip revision arthroplasty

Intervention Type PROCEDURE

No-drainage

Patients without drainage after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* septic loosening,
* primary or secondary coagulopathy,
* renal or hepatic failure,
* thromboembolism in past history
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prof A Gruca Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bartosz Paweł

M.D., Ph.D. Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pawel Bartosz

Role: PRINCIPAL_INVESTIGATOR

Gruca Teaching Hospital, Centre of Postgraduate Medical Education in Otwock

Other Identifiers

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GrucaTH

Identifier Type: -

Identifier Source: org_study_id

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