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Clinical Analysis of Suction Drainage in Cementless Hip Replacement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04333264
Enrollment
100
Registered
2020-04-03
Start date
2016-03-31
Completion date
2020-02-29
Last updated
2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Hip

Keywords

hip, arthroplasty, suction, drainage

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.

Interventions

PROCEDUREsuction drainage

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

PROCEDUREno suction drainage

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

Sponsors

Bartosz Paweł
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood transfusion14 days after surgeryNeed of blood transfusion after operation
Wound exudation3 days after surgeryAssessing wound dehiscence after surgery, 1-exudation appear, 0-dry dressing
Soft tissue hematoma3 days after surgeryUSG hematoma appearance in soft tissue around the hip
Intraoperative bleeding1 dayAll amount of blood loss intraoperative with hidden bleeding, with use of Gross formula.
Hip hematoma size in USG3 days after surgerySize in millimeters fluid collection in supine position above femoral neck.
Hemoglobin levels3 days after surgeryHb levels after surgery, difference between two groups
C-reactive protein levels3 days after surgeryC-reactive protein levels after surgery, difference between two groups
Visual Analog Scale punctation3 day after surgeryPain level after surgery in Visual Analog Scale scale 0-10 pts. where 0-no pain, 10-most painful.
Hip range of movement3 days after surgeryDifferences between hip ROM after surgery

Secondary

MeasureTime frameDescription
Deep vein thrombosis30 days after surgeryOccurrence lower limb thrombosis after surgery
Readmission30 days after surgeryNeed to readmission after surgery
Infection30 days after surgerySuperficial or deep infection after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026