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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXA | Active Comparator | 1.5g of TXA was diluted in 100 mL of saline and applied intraoperatively into the joint capsule prior to closure. |
|
| 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, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fibrin sealant | Drug | Fibrin sealant contains human thrombin and fibrinogen, aiding platelet activation, aggregation, and fibrin clot formation. |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age in years | Preoperatively |
| Sex | Sex | Preoperatively |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming Han Lincoln Liow | Singapore General Hospital | Principal Investigator |
| Azmi Rahman | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital Department of Orthopaedics | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38138181 | Background | 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. | |
| 27773860 | Background |
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Data collected solely as part of this study will not be shared or used for alternative study purposes.
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| 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. |
|
| 6 months post-operatively |
| PROMs - SF-36 | SF-36 Score (0-100, higher is better) | 6 months post-operatively |
| BMI |
Height and weight summarised to BMI (kg/m2) |
| Preoperatively |
| 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. |
| 27317900 | 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. |
| 29916929 | 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. |
| D003509 |
| Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |