A Trial of Intraoperative Fibrin Sealant on Postoperative Recovery After Total Knee Replacement

A Prospective Randomised Pilot Trial Of The Supplemental Use Of Intraoperative Fibrin Sealant Alongside TXA On Postoperative Recovery After Total Knee Replacement

This study is conducted as a pilot trial to assess the added benefit of the VeraSeal fibrin sealant to TXA on postoperative outcomes following TKR. Informed consent is obtained from all participants prior to inclusion in the study. Patients are prospectively recruited from a consecutive series of TKR procedures performed for end-stage osteoarthritis. Recruited patients were randomised into two cohorts: those receiving intra-articular tranexamic acid (TXA) alone, and those receiving intra-articular TXA and VeraSeal fibrin sealant (TXA+Sealant). Randomisation is performed just prior to surgery using a digital random allocation generator by the surgical team. Patients and physiotherapists responsible for outcome data collection are blinded to group allocation throughout the study period.

Intraoperative administration of the sealant is performed after prosthetic implantation, which was followed by topical intra-articular TXA. In the TXA group, TXA is applied intraoperatively into the joint capsule prior to closure. In the TXA+Sealant group, VeraSeal was applied evenly onto subcutaneous tissues, synovium and exposed bony surfaces within the joint capsule and allowed to cure. The same dose of topical TXA was infiltrated after VeraSeal had cured, prior to closure. All other pathways were standard per hospital protocols.

Preoperatively, demographic data including age, sex, height, and weight, as well as serum haemoglobin (Hb) levels were collected for all patients. Primary outcomes were collected on postoperative day 1: serum Hb, knee flexion range of motion (°), ambulation distance (m), and rest and ambulatory pain visual analogue scales (VAS) between 0 (no pain) and 10 (worst pain) were collected. All patients were inpatient during primary outcome data collection. Secondary outcomes included: Oxford Knee Score (0-48, higher is better), American Knee Society Score (0-100, higher is better), and SF-36 Score (0-100, higher is better), collected pre-operatively and 6 months post-operatively.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis of the Knee
• Intervention / Treatment: Drug: Tranexamic Acid (TXA); Drug: fibrin sealant

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore General Hospital Department of Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Fits clinically-assessed criteria for total knee replacement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TXA; 1.5g of TXA was diluted in 100 mL of saline and applied intraoperatively into the joint capsule prior to closure.	Drug: Tranexamic Acid (TXA); Topical Tranexamic Acid (TXA) is an antifibrinolytic agent which stabilises clot formation and is infiltrated into local tissues perioperatively prior to closure.
Experimental: TXA+Sealant; VeraSeal was applied evenly onto subcutaneous tissues, synovium and exposed bony surfaces within the joint capsule and allowed to cure and form clots for 60 seconds. Following this, 1.5g of TXA was diluted in 100 mL of saline and applied intraoperatively into the joint capsule prior to closure,	Drug: Tranexamic Acid (TXA); Topical Tranexamic Acid (TXA) is an antifibrinolytic agent which stabilises clot formation and is infiltrated into local tissues perioperatively prior to closure.; Drug: fibrin sealant; Fibrin sealant contains human thrombin and fibrinogen, aiding platelet activation, aggregation, and fibrin clot formation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Hb	Serum Haemoglobin (g/dL)	Preoperatively and one day after surgery
Knee Flexion ROM	Knee flexion range of motion (°)	Preoperatively and one day after surgery
Ambulation Distance	Ambulation distance (m)	One day after surgery
Rest Pain Score	Rest pain visual analogue scales (VAS) between 0 (no pain) and 10 (worst pain)	One day after surgery
Ambulatory Pain Score	Ambulatory pain visual analogue scales (VAS) between 0 (no pain) and 10 (worst pain)	One day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMs - OKS	Oxford Knee Score (0-48, higher is better)	Pre-operatively and 6 months post-operatively
PROMs - AKSS	American Knee Society Score (0-100, higher is better)	6 months post-operatively
PROMs - SF-36	SF-36 Score (0-100, higher is better)	6 months post-operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age in years	Preoperatively
Sex	Sex	Preoperatively
BMI	Height and weight summarised to BMI (kg/m2)	Preoperatively

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Investigators: Principal Investigator: Ming Han Lincoln Liow, Singapore General Hospital; Principal Investigator: Azmi Rahman, Singapore General Hospital

Publications and helpful links

General Publications

• Liu CH, Chang CH, Chang YH, Shih HN, Hu CC. Topical Fibrin Sealant (Tisseel@) Does Not Provide a Synergic Blood-Conservation Effect with Tranexamic Acid in Total Knee Arthroplasty-A Prospective Randomized Controlled Trial. Medicina (Kaunas). 2023 Nov 26;59(12):2078. doi: 10.3390/medicina59122078.
• Li J, Li HB, Zhai XC, Qin-Lei, Jiang XQ, Zhang ZH. Topical use of topical fibrin sealant can reduce the need for transfusion, total blood loss and the volume of drainage in total knee and hip arthroplasty: A systematic review and meta-analysis of 1489 patients. Int J Surg. 2016 Dec;36(Pt A):127-137. doi: 10.1016/j.ijsu.2016.10.022. Epub 2016 Oct 20.
• Gao F, Ma J, Sun W, Guo W, Li Z, Wang W. Topical fibrin sealant versus intravenous tranexamic acid for reducing blood loss following total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2016 Aug;32:31-7. doi: 10.1016/j.ijsu.2016.06.009. Epub 2016 Jun 16.
• Abdel MP, Chalmers BP, Taunton MJ, Pagnano MW, Trousdale RT, Sierra RJ, Lee YY, Boettner F, Su EP, Haas SB, Figgie MP, Mayman DJ. Intravenous Versus Topical Tranexamic Acid in Total Knee Arthroplasty: Both Effective in a Randomized Clinical Trial of 640 Patients. J Bone Joint Surg Am. 2018 Jun 20;100(12):1023-1029. doi: 10.2106/JBJS.17.00908.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Carboxylic Acids; Blood Proteins; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Fibrin; Tranexamic Acid; Fibrin Tissue Adhesive
• Other Study ID Numbers: 2024-4046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data collected solely as part of this study will not be shared or used for alternative study purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No