Back to results

Clinical Analysis of Suction Drainage in Cementless Hip Replacement

Primary Purpose

Arthropathy of Hip

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

suction drainage

no suction drainage

About this trial

This is an interventional treatment trial for Arthropathy of Hip focused on measuring hip, arthroplasty, suction, drainage

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

age between 30-80
primary hip osteoarthritis

Exclusion Criteria:

secondary hip osteoarthritis
autoimmune disease
congenital or secondary coagulopathy
vein or artery thrombosis
renal or liver failure
cemented or hybrid alloplasty,
no consent from the patient

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

suction drainage

no suction drainage

Arm Description

Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty

Outcomes

Primary Outcome Measures

Hip hematoma size in USG

Size in millimeters fluid collection in supine position above femoral neck.

Hemoglobin levels

Hb levels after surgery, difference between two groups

C-reactive protein levels

C-reactive protein levels after surgery, difference between two groups

Visual Analog Scale punctation

Pain level after surgery in Visual Analog Scale scale 0-10 pts. where 0-no pain, 10-most painful.

Hip range of movement

Differences between hip ROM after surgery

Wound exudation

Assessing wound dehiscence after surgery, 1-exudation appear, 0-dry dressing

Soft tissue hematoma

USG hematoma appearance in soft tissue around the hip

Intraoperative bleeding

All amount of blood loss intraoperative with hidden bleeding, with use of Gross formula.

Blood transfusion

Need of blood transfusion after operation

Secondary Outcome Measures

Infection

Superficial or deep infection after surgery

Deep vein thrombosis

Occurrence lower limb thrombosis after surgery

Readmission

Need to readmission after surgery

Full Information

NCT ID

NCT04333264

First Posted

March 30, 2020

Last Updated

April 1, 2020

Sponsor

Bartosz Paweł

1. Study Identification

Unique Protocol Identification Number

NCT04333264

Brief Title

Clinical Analysis of Suction Drainage in Cementless Hip Replacement

Official Title

Clinical Analysis of Suction Drainage in Cementless Hip Replacement - a Prospective Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

March 2016 (Actual)

Primary Completion Date

January 2020 (Actual)

Study Completion Date

February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bartosz Paweł

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Randomized prospective study assessing suction drainage in total hip arthroplasty. Group without drainage, 50 hips, compared with group with suction drainage, 50 hips. Both groups will be asses clinically (ROM scale, VAS), laboratory and radiology (USG). In the actually literature there are no benefits using closed suction drainage after primary total hip arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthropathy of Hip

Keywords

hip, arthroplasty, suction, drainage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two groups of patients with or without closed suction drainage after primary total hip arthroplasty.

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

suction drainage

Arm Type

Active Comparator

Arm Description

Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty

Arm Title

no suction drainage

Arm Type

Active Comparator

Arm Description

Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty

Intervention Type

Procedure

Intervention Name(s)

suction drainage

Intervention Description

After primary total hip arthroplasty closed suction drainage will be used.

Intervention Type

Procedure

Intervention Name(s)

no suction drainage

Intervention Description

After primary total hip arthroplasty closed suction drainage won't be used.

Primary Outcome Measure Information:

Title

Hip hematoma size in USG

Description

Size in millimeters fluid collection in supine position above femoral neck.

Time Frame

3 days after surgery

Title

Hemoglobin levels

Description

Hb levels after surgery, difference between two groups

Time Frame

3 days after surgery

Title

C-reactive protein levels

Description

C-reactive protein levels after surgery, difference between two groups

Time Frame

3 days after surgery

Title

Visual Analog Scale punctation

Description

Pain level after surgery in Visual Analog Scale scale 0-10 pts. where 0-no pain, 10-most painful.

Time Frame

3 day after surgery

Title

Hip range of movement

Description

Differences between hip ROM after surgery

Time Frame

3 days after surgery

Title

Wound exudation

Description

Assessing wound dehiscence after surgery, 1-exudation appear, 0-dry dressing

Time Frame

3 days after surgery

Title

Soft tissue hematoma

Description

USG hematoma appearance in soft tissue around the hip

Time Frame

3 days after surgery

Title

Intraoperative bleeding

Description

All amount of blood loss intraoperative with hidden bleeding, with use of Gross formula.

Time Frame

1 day

Title

Blood transfusion

Description

Need of blood transfusion after operation

Time Frame

14 days after surgery

Secondary Outcome Measure Information:

Title

Infection

Description

Superficial or deep infection after surgery

Time Frame

30 days after surgery

Title

Deep vein thrombosis

Description

Occurrence lower limb thrombosis after surgery

Time Frame

30 days after surgery

Title

Readmission

Description

Need to readmission after surgery

Time Frame

30 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age between 30-80 primary hip osteoarthritis Exclusion Criteria: secondary hip osteoarthritis autoimmune disease congenital or secondary coagulopathy vein or artery thrombosis renal or liver failure cemented or hybrid alloplasty, no consent from the patient

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pawel Bartosz

Organizational Affiliation

Prof. A. Gruca Teaching Hospital in Otwock

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

34389016

Citation

Bartosz P, Marczynski W, Para M, Kogut M, Bialecki J. Comparative study of suction drainage placement in cementless hip replacement among patients undergoing extended thromboprophylaxis: a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 13;22(1):688. doi: 10.1186/s12891-021-04583-0.

Results Reference

derived

Learn more about this trial

Clinical Analysis of Suction Drainage in Cementless Hip Replacement

We'll reach out to this number within 24 hrs