Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA

NCT02266407 | Completed DMC

• 1 other identifier: TD-07711
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the surgical and economic effectiveness of the Aquamantys System in managing intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing both aseptic and septic revision total knee arthroplasty.

Conditions

Infection of Total Knee Joint Prosthesis; Aseptic Loosening of Prosthetic Joint

Keywords

Revision TKA; Septic; Aseptic; Transfusion; Blood Loss

Outcome Measures

Primary Outcomes (1)

• Blood Loss and Post-Operative Transfusion Rate

  To reduce blood loss and post-operative transfusion rates in patients undergoing total joint arthroplasty. This will be achieved using the Aquamantys system. The Aquamantys system provides transcollation which shrinks the collagen fibers in the walls of blood vessels, effectively sealing the blood vessels up to 1mm in diameter, resulting in the reduction of bleeding from soft tissue.

  14 days

Secondary Outcomes (1)

• Operative room and total hospital costs

  14 days

Other Outcomes (1)

• Change in hemoglobin and hematocrit from baseline (pre-op)

  14 days

Study Arms (2)

ASEPTIC Revision TKA & Aquamantys System

ACTIVE COMPARATOR

Single-stage revision TKA cases performed for aseptic failure requiring an extended osteotomy for component removal and intra-operative blood management (bipolar sealing) with the Aquamantys® System. These will be compared to in-house matched historic control using patients presenting with ASEPTIC failed primary TKA and revised without use of the Aquamantys® System.

Procedure: Aquamantys System

SEPTIC Revision TKA & Aquamantys System

ACTIVE COMPARATOR

Single-stage revision TKA cases performed for septic failure requiring an extended osteotomy for component removal and intra-operative blood management (bipolar sealing) with the Aquamantys® System. These will be compared to in-house matched historic control using patients presenting with SEPTIC failed primary TKA revised without use of the Aquamantys® System.

Procedure: Aquamantys System

Interventions

Aquamantys System PROCEDURE

The use of the saline-coupled bipolar sealing technology (Aquamantys® System, Medtronic Advanced Energy, LLC, Portsmouth, NH, USA) uses bipolar radiofrequency energy combined with a continuous-flow saline at the electrode tip to prevent tissue temperatures from exceeding 100 °C thus minimizing tissue charring. The temperature achieved is sufficient to induce a process called Transcollation(TM) which shrinks the collagen fibers in the walls of blood vessels, effectively sealing the blood vessels up to 1mm in diameter, resulting in the reduction of bleeding from soft tissue.

ASEPTIC Revision TKA & Aquamantys System; SEPTIC Revision TKA & Aquamantys System

Eligibility Criteria

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

You may qualify if:

• The patient is greater than 18 years of age
• Patients following failure of primary, unilateral TKA
• The degree of revision requires the use of an extended osteotomy for component removal
• Patient has participated in the informed consent process and has signed an Ethics Committee approved informed consent

You may not qualify if:

• Patients presenting with a history of bleeding disorders and/or are on chronic blood anticoagulation therapy
• Patients presenting with an internal cardiac defibrillator
• Women who are pregnant
• Prisoner or transient
• Recent history of known narcotic abuse
• Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires
• Subject unwilling to undergo blood transfusion, if necessary

Sponsors & Collaborators

• Medtronic Surgical Technologies: lead

Study Sites (1)

Orthopädische Klinik Markgröningen gGmbH

Markgröningen, 71706, Germany

Location

Related Publications (5)

• Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002.

  PMID: 9973048 BACKGROUND

• 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.

  PMID: 20145794 BACKGROUND

• 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.

  PMID: 16525984 BACKGROUND

• 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.

  PMID: 19675727 BACKGROUND

• Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty. 2007 Jun;22(4 Suppl 1):82-5. doi: 10.1016/j.arth.2007.02.018.

  PMID: 17570284 BACKGROUND

MeSH Terms

Conditions

Infertility; Hemorrhage

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Palaniswamy Vijay, PhD

  Medtronic Surgical Technologies

  STUDY DIRECTOR

• Joachim Singer, Dr.med.

  Orthopädische Klinik Markgröningen gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 17, 2014
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)