Clinical Analysis of Suction Drainage in Cementless Hip Replacement

NCT04333264 | Completed

• 1 other identifier: 1/032016
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthropathy of Hip

Keywords

hip; arthroplasty; suction; drainage

Outcome Measures

Primary Outcomes (9)

• Hip hematoma size in USG

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

  3 days after surgery

• Hemoglobin levels

  Hb levels after surgery, difference between two groups

  3 days after surgery

• C-reactive protein levels

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

  3 days after surgery

• Visual Analog Scale punctation

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

  3 day after surgery

• Hip range of movement

  Differences between hip ROM after surgery

  3 days after surgery

• Wound exudation

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

  3 days after surgery

• Soft tissue hematoma

  USG hematoma appearance in soft tissue around the hip

  3 days after surgery

• Intraoperative bleeding

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

  1 day

• Blood transfusion

  Need of blood transfusion after operation

  14 days after surgery

Secondary Outcomes (3)

• Infection

  30 days after surgery

• Deep vein thrombosis

  30 days after surgery

• Readmission

  30 days after surgery

Study Arms (2)

suction drainage

ACTIVE COMPARATOR

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

Procedure: suction drainage

no suction drainage

ACTIVE COMPARATOR

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

Procedure: no suction drainage

Interventions

suction drainage PROCEDURE

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

suction drainage

no suction drainage PROCEDURE

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

no suction drainage

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 30-80
• primary hip osteoarthritis

You may not qualify if:

• 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

Sponsors & Collaborators

• Bartosz Paweł: lead

Related Publications (1)

• 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.

  PMID: 34389016 DERIVED

MeSH Terms

Interventions

Suction

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Study Officials

• Pawel Bartosz

  Prof. A. Gruca Teaching Hospital in Otwock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

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

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 3, 2020
• Study Start: March 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 3, 2020

Record last verified: 2020-04