NCT03952546

To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty

Completed NA Results posted Last updated 15 February 2023

What this trial tests

NA trial testing Saline-coupled Bipolar Sealer in Surgical Blood Loss in 211 participants. Completed in 9 June 2021.

Timeline

7 May 2019

Primary endpoint
9 June 2021

9 June 2021

Quick facts

Lead sponsor	Northwell Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	211
Start date	7 May 2019
Primary completion	9 June 2021
Estimated completion	9 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Saline-coupled Bipolar Sealer
• Unipolar electrocautery

Conditions studied

• Surgical Blood Loss — all drugs for Surgical Blood Loss →

Sponsor

Northwell Health — full company profile →

Who can join

18 and older, any sex, with Surgical Blood Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hemostasis Primary · Postoperative day 1

Postoperative day 1 estimated blood loss as calculated by the Gross' Formula

Group	Value	95% CI
Treatment Arm	924	178 – 1861
Control Arm	1062	218 – 2053

Functional Outcomes Secondary · 8 weeks

Functional outcomes measured by the 2011 "Knee Society Score". The Functional Activities section consists of 4 sub-sections with a total score ranging from 0-100 points. The higher the numerical value the better the outcome. The sub-sections consist of: (1)Walking and Standing 0-30 points (2)Standard Activities 0-30 points (3)Advanced Activities 0-25 points (4)Discretionary Knee Activities 0-15 points.

Group	Value	95% CI
Treatment Arm	56.45	51.57 – 61.34
Control Arm	61.79	58.19 – 65.39

Wound Infection Secondary · 90 days postoperatively

Participants were assessed for any wound infection within 90 days of surgery.

Group	Value	95% CI
Saline-Coupled Bipolar Sealer	1
Unipolar Electrocautery	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days. Reporting threshold: 1.2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Saline-Coupled Bipolar Sealer

Serious: 0/82 (0%)

Deaths: 0/82

Unipolar Electrocautery

Serious: 0/82 (0%)

Deaths: 0/82

Other adverse events (1 terms — click to expand)

Reaction	System	Saline-Coupled Bipolar Sea…	Unipolar Electrocautery
Wound Infection	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT03952546 adverse events section.

Sponsor's own description

The purpose of this study is to investigate whether the saline-coupled bipolar sealer compared to the unipolar electrocautery provides superior hemostasis in patients undergoing primary unilateral total knee arthroplasty. This will be a prospective, randomized, single-blinded, non-inferiority study in patients scheduled for a primary unilateral total knee arthroplasty (TKA) with Dr. Eugene Krauss or Dr. Ayal Segal. The restriction of this study to two surgeons will limit variations in the outcomes being measured due to differences in surgical technique.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of the Unipolar Electrocautery and the Bipolar Sealer in Reducing Blood Loss in Total Knee Arthroplasty: A Prospective, Randomized, Noninferiority Study.
   Krauss ES, Segal A, Simonson BG, Dengler N, et al · · 2024 · cited 1× · PMID 39376671 · DOI 10.1016/j.artd.2024.101509