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

NCT07455591 | Completed Phase 4

• 1 other identifier: 2024-4046
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteo Arthritis of the Knee

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• PROMs - OKS

  Pre-operatively and 6 months post-operatively

• PROMs - AKSS

  6 months post-operatively

• PROMs - SF-36

  6 months post-operatively

Other Outcomes (3)

• Age

  Preoperatively

• Sex

  Preoperatively

• BMI

  Preoperatively

Study Arms (2)

TXA

ACTIVE COMPARATOR

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)

TXA+Sealant

EXPERIMENTAL

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: fibrin sealant; Drug: Tranexamic Acid (TXA)

Interventions

fibrin sealant DRUG

Fibrin sealant contains human thrombin and fibrinogen, aiding platelet activation, aggregation, and fibrin clot formation.

TXA+Sealant

Tranexamic Acid (TXA) DRUG

Topical Tranexamic Acid (TXA) is an antifibrinolytic agent which stabilises clot formation and is infiltrated into local tissues perioperatively prior to closure.

TXA; TXA+Sealant

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fits clinically-assessed criteria for total knee replacement

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital Department of Orthopaedics

Singapore, Singapore

Location

Related Publications (4)

• 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.

  PMID: 38138181 BACKGROUND

• 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.

  PMID: 27773860 BACKGROUND

• 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.

  PMID: 27317900 BACKGROUND

• 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.

  PMID: 29916929 BACKGROUND

MeSH Terms

Interventions

Fibrin Tissue Adhesive; Tranexamic Acid

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ming Han Lincoln Liow

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Azmi Rahman

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Orthopaedic Surgery (Adult Reconstruction)

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 6, 2026
• Study Start: January 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)