NCT02427711

Brief Summary

To investigate if the use of a bipolar sealer for skin and capsula incision results in decreased total blood loss and/or less blood transfusion in non-septic knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 17, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

April 20, 2015

Last Update Submit

August 13, 2015

Conditions

Total Blood Loss

Keywords

Reduction of blood loss for revisions of knee arthroplastyblood transfusionsReadmissionBipolar sealer

Outcome Measures

Primary Outcomes (1)

  • Estimated blood loss

    2nd postoperative morning

Secondary Outcomes (3)

  • Blood loss

    1st. postoperative morning

  • Blood transfusion

    while hospitalized expected 5 days.

  • Readmission

    90 days after surgery

Study Arms (2)

Bipolar sealer

ACTIVE COMPARATOR

Prospective use of bipolar sealer for skin and knee capsule incision revisions of non-septic knee arthroplasty.

Device: Bipolar sealer

Scalpel

PLACEBO COMPARATOR

Conventional surgical incision with scalpel - data extracted from a retrospective group.

Device: Bipolar sealer

Interventions

Bipolar sealerDEVICE

Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.

Also known as: Aquamantys
Bipolar sealerScalpel

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing Non septic knee-arthroplasty revision.
  • Musk speak and understand Danish

You may not qualify if:

  • Age below 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Denmark

Location

MeSH Terms

Conditions

Exsanguination

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 28, 2015

Study Start

October 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 17, 2015

Record last verified: 2015-04

Locations

DK(1)