OsteoarthritisNCT01736644
Bipolar Sealer Aquamantys Use in Total Knee Replacement
A study testing Electrocautery and Bipolar sealer Aquamantys in people with Osteoarthritis and Arthritis, run by Medtronic Surgical Technologies at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Arthritis, Surgery
- What is being tested?
- Electrocautery and Bipolar sealer Aquamantys
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2012to 27 Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
South West London Elective Orthopaedic Center
Epsom, Surrey, Kt18 7EG
Freeman Hospital
Newcastle upon Tyne
About this study
Official title: A Prospective Randomized Control Trial to Compare the Aquamantys System With Standard Electrocautery in Reducing Blood Loss in Primary Total Knee Arthroplasty
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.
- Conditions
- Osteoarthritis, Arthritis, Surgery, Infection, Inflammation, Disability
- Being tested
- Electrocautery, Bipolar sealer Aquamantys
- Keywords
- blood loss, bipolar sealer, aquamantys, total knee replacement, primary total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Arthritis, Infections, Inflammation, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocauteryDevice
Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery
Bipolar sealer AquamantysDevice
Also called Aquamantys, AQM, Bipolar sealer
Aquamantys use in tourniquet and tourniquetless total knee replacement.
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery | Placebo comparator | Use of electrocautery in tourniquet and without tourniquet total knee replacement surgery. Receives: Device: Electrocautery |
| Bipolar Sealer Aquamantys | Active comparator | Use of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures. Receives: Device: Bipolar sealer Aquamantys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Loss
The primary outcome will be total blood loss throughout the hospital stay.
Measured: upto to 72 hrs after surgery
Secondary outcomes (1)
Rehabilitation
Discharge criteria evaluated.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startOct 2012
- Primary completion27 Oct 2013
- Study completion27 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard E Field, Md, PhD, FRCS, Principal investigator, SWLEOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736644
- Sponsor's protocol ID
- TD-07709
- Status last verified
- Feb 2020
- First submitted
- 20 Nov 2012
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20145794Marulanda 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.
PubMed 16525984Pfeiffer 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.
PubMed 19675727
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Control Trial to Compare the Aquamantys System With Standard Electrocautery in Reducing Blood Loss in Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01736644
- Acronym / sponsor ID
- TD-07709
- Conditions
- Osteoarthritis, Arthritis, Surgery, Infection, Inflammation, Disability
- Keywords
- blood loss, bipolar sealer, aquamantys, total knee replacement, primary total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012 (actual)
- Primary completion
- 27 Oct 2013 (actual)
- Study completion
- 27 Oct 2013 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocautery | Placebo comparator | Device: ElectrocauteryUse of electrocautery in tourniquet and without tourniquet total knee replacement surgery. |
| Bipolar Sealer Aquamantys | Active comparator | Device: Bipolar sealer AquamantysUse of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocauteryUse of electrocautery in tourniquet and tourniquetless total knee replacement surgery | Device | Electrocautery |
| Bipolar sealer AquamantysAlso: Aquamantys, AQM, Bipolar sealerAquamantys use in tourniquet and tourniquetless total knee replacement. | Device | Bipolar Sealer Aquamantys |
Primary outcome
Blood Loss
Time frame: upto to 72 hrs after surgery
The primary outcome will be total blood loss throughout the hospital stay.
1 secondary outcome
Rehabilitation
Time frame: 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Background: PubMed 20145794Marulanda 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.
- Background: PubMed 16525984Marulanda 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.
- Background: PubMed 19675727Pfeiffer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard E Field, Md, PhD, FRCS principal investigator
SWLEOC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocautery and Bipolar sealer Aquamantys in people with Osteoarthritis and Arthritis, run by Medtronic Surgical Technologies at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Loss (time frame: upto to 72 hrs after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01736644, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.