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Bipolar Sealer Aquamantys Use in Total Knee Replacement

Primary Purpose

Osteoarthritis, Arthritis, Surgery

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Electrocautery

Bipolar sealer Aquamantys

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring blood loss, bipolar sealer, aquamantys, total knee replacement, primary total knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is ≥18 years of age
Patient has failed conservative therapy of osteoarthritis of the knee and has been listed to undergo primary TKA
Patient is willing and able to provide written informed consent.
Pre-assessment Haemoglobin ≥ 11.0g/dl
Patient is suitable to receive spinal anaesthesia with no peripheral nerve blocks
Patients willing to undergo blood transfusion

Exclusion Criteria:

Patients that are listed for unicondylar or revision TKA
Patients who are being converted from a previous high tibial osteotomy and a previous unicondylar knee arthroplasty
Fixed motor deficit thus affecting functional assessment of the knee
Patients presenting with a non-osteoarthritis degenerative knee diagnosis
Patients presenting with known contralateral knee osteoarthritis requiring simultaneous bilateral TKA
Patients presenting with a history of previous knee infection
Patients presenting with a pre-operative knee range of motion < 85°
Knee deformity greater than 20 degrees varus or valgus
Patients presenting with a history of bleeding disorders and/or are on chronic blood anticoagulation therapy
Patients with significantly impaired renal function (defined by EGFR >30)
Patients with allergy or sensitivity to non-steroidal anti-inflammatory drugs, ropivacaine, ketoprofen or adrenaline
Patients presenting with an internal cardiac defibrillator
Women who are pregnant
Evidence of active (systemic or local) infection at time of surgery
Patients who have habitual opioid use
Patients who have a psychiatric or mental illness which could impair the consent process or ability to complete patient-report questionnaires
Morbid obesity [BMI > 40]
Patients who are unwilling to undergo blood transfusion, if necessary
Patients who are receiving any implant used in conjunction with a customised-cutting block system
Any patient who cannot or will not provide written informed consent for participation in the study
Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems

Sites / Locations

South West London Elective Orthopaedic Center
Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Electrocautery

Bipolar Sealer Aquamantys

Arm Description

Use of electrocautery in tourniquet and without tourniquet total knee replacement surgery.

Use of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures.

Outcomes

Primary Outcome Measures

Blood Loss

The primary outcome will be total blood loss throughout the hospital stay.

Secondary Outcome Measures

Rehabilitation

Discharge criteria evaluated.

Full Information

NCT ID

NCT01736644

First Posted

November 20, 2012

Last Updated

February 25, 2020

Sponsor

Medtronic Surgical Technologies

1. Study Identification

Unique Protocol Identification Number

NCT01736644

Brief Title

Bipolar Sealer Aquamantys Use in Total Knee Replacement

Official Title

A Prospective Randomized Control Trial to Compare the Aquamantys System With Standard Electrocautery in Reducing Blood Loss in Primary Total Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

October 2012 (Actual)

Primary Completion Date

October 27, 2013 (Actual)

Study Completion Date

October 27, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Surgical Technologies

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will compare the clinical outcomes for patients undergoing a total knee replacement using a bipolar sealer, the Aquamantys® System, as compared to standard electrocautery. Total blood loss during the hospital stay and knee mobility and discharge factors will be analyzed.

6. Conditions and Keywords

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

Osteoarthritis, Arthritis, Surgery, Infection, Inflammation, Disability, Hemorrhage

Keywords

blood loss, bipolar sealer, aquamantys, total knee replacement, primary total knee arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electrocautery

Arm Type

Placebo Comparator

Arm Description

Use of electrocautery in tourniquet and without tourniquet total knee replacement surgery.

Arm Title

Bipolar Sealer Aquamantys

Arm Type

Active Comparator

Arm Description

Use of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures.

Intervention Type

Device

Intervention Name(s)

Electrocautery

Intervention Description

Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery

Intervention Type

Device

Intervention Name(s)

Bipolar sealer Aquamantys

Other Intervention Name(s)

Aquamantys, AQM, Bipolar sealer

Intervention Description

Aquamantys use in tourniquet and tourniquetless total knee replacement.

Primary Outcome Measure Information:

Title

Blood Loss

Description

The primary outcome will be total blood loss throughout the hospital stay.

Time Frame

upto to 72 hrs after surgery

Secondary Outcome Measure Information:

Title

Rehabilitation

Description

Discharge criteria evaluated.

Time Frame

6-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is ≥18 years of age Patient has failed conservative therapy of osteoarthritis of the knee and has been listed to undergo primary TKA Patient is willing and able to provide written informed consent. Pre-assessment Haemoglobin ≥ 11.0g/dl Patient is suitable to receive spinal anaesthesia with no peripheral nerve blocks Patients willing to undergo blood transfusion Exclusion Criteria: Patients that are listed for unicondylar or revision TKA Patients who are being converted from a previous high tibial osteotomy and a previous unicondylar knee arthroplasty Fixed motor deficit thus affecting functional assessment of the knee Patients presenting with a non-osteoarthritis degenerative knee diagnosis Patients presenting with known contralateral knee osteoarthritis requiring simultaneous bilateral TKA Patients presenting with a history of previous knee infection Patients presenting with a pre-operative knee range of motion < 85° Knee deformity greater than 20 degrees varus or valgus Patients presenting with a history of bleeding disorders and/or are on chronic blood anticoagulation therapy Patients with significantly impaired renal function (defined by EGFR >30) Patients with allergy or sensitivity to non-steroidal anti-inflammatory drugs, ropivacaine, ketoprofen or adrenaline Patients presenting with an internal cardiac defibrillator Women who are pregnant Evidence of active (systemic or local) infection at time of surgery Patients who have habitual opioid use Patients who have a psychiatric or mental illness which could impair the consent process or ability to complete patient-report questionnaires Morbid obesity [BMI > 40] Patients who are unwilling to undergo blood transfusion, if necessary Patients who are receiving any implant used in conjunction with a customised-cutting block system Any patient who cannot or will not provide written informed consent for participation in the study Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard E Field, Md, PhD, FRCS

Organizational Affiliation

SWLEOC

Official's Role

Principal Investigator

Facility Information:

Facility Name

South West London Elective Orthopaedic Center

City

Epsom

State/Province

Surrey

ZIP/Postal Code

Kt18 7EG

Country

United Kingdom

Facility Name

Freeman Hospital

City

Newcastle upon Tyne

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

20145794

Citation

Marulanda GA, Krebs VE, Bierbaum BE, Goldberg VM, Ries M, Ulrich SD, Seyler TM, Mont MA. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):E179-83.

Results Reference

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PubMed Identifier

16525984

Citation

Marulanda GA, Ragland PS, Seyler TM, Mont MA. Reductions in blood loss with use of a bipolar sealer for hemostasis in primary total knee arthroplasty. Surg Technol Int. 2005;14:281-6.

Results Reference

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PubMed Identifier

19675727

Citation

Pfeiffer M, Brautigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study. Ger Med Sci. 2005 Dec 13;3:Doc10.

Results Reference

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Bipolar Sealer Aquamantys Use in Total Knee Replacement

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