NCT07455591

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-08-30
• Completion: 2025-12-30
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Singapore