Osteo Arthritis of the KneePhase 4NCT07455591
A Trial of Intraoperative Fibrin Sealant on Postoperative Recovery After Total Knee Replacement
A Phase 4 study testing fibrin sealant and Tranexamic Acid (TXA) in people with Osteo Arthritis of the Knee, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteo Arthritis of the Knee
- What is being tested?
- fibrin sealant and Tranexamic Acid (TXA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2024to 30 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fits clinically-assessed criteria for total knee replacement
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore General Hospital Department of Orthopaedics
Singapore
About this study
Official title: 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.
- Conditions
- Osteo Arthritis of the Knee
- Being tested
- fibrin sealant, Tranexamic Acid (TXA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrin sealantDrug
Fibrin sealant contains human thrombin and fibrinogen, aiding platelet activation, aggregation, and fibrin clot formation.
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.
| Study group | Role | What they receive |
|---|---|---|
| TXA | Active comparator | 1.5g of TXA was diluted in 100 mL of saline and applied intraoperatively into the joint capsule prior to closure. Receives: 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, Receives: Drug: fibrin sealant; Drug: Tranexamic Acid (TXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Hb
Serum Haemoglobin (g/dL)
Measured: Preoperatively and one day after surgery
Knee Flexion ROM
Knee flexion range of motion (°)
Measured: Preoperatively and one day after surgery
Ambulation Distance
Ambulation distance (m)
Measured: One day after surgery
Rest Pain Score
Rest pain visual analogue scales (VAS) between 0 (no pain) and 10 (worst pain)
Measured: One day after surgery
Ambulatory Pain Score
Ambulatory pain visual analogue scales (VAS) between 0 (no pain) and 10 (worst pain)
Measured: One day after surgery
Secondary outcomes (3)
PROMs - OKS
Oxford Knee Score (0-48, higher is better)
Measured: Pre-operatively and 6 months post-operatively
PROMs - AKSS
American Knee Society Score (0-100, higher is better)
Measured: 6 months post-operatively
PROMs - SF-36
SF-36 Score (0-100, higher is better)
Measured: 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jan 2024
- Primary completion30 Aug 2024
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lincoln Liow Ming Han, Singapore General Hospital
- Investigators
- Ming Han Lincoln Liow, Principal investigator, Singapore General HospitalAzmi Rahman, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455591
- Sponsor's protocol ID
- 2024-4046
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected solely as part of this study will not be shared or used for alternative study purposes.
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.
PubMed 38138181Li 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.
PubMed 27773860Gao 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.
PubMed 27317900Abdel 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.
PubMed 29916929
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Pilot Trial Of The Supplemental Use Of Intraoperative Fibrin Sealant Alongside TXA On Postoperative Recovery After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT07455591
- Acronym / sponsor ID
- 2024-4046
- Conditions
- Osteo Arthritis of the Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA | Active comparator | Drug: Tranexamic Acid (TXA)1.5g of TXA was diluted in 100 mL of saline and applied intraoperatively into the joint capsule prior to closure. |
| TXA+Sealant | Experimental | Drug: fibrin sealant, Drug: Tranexamic Acid (TXA)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, |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fits clinically-assessed criteria for total knee replacement
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fibrin sealantFibrin sealant contains human thrombin and fibrinogen, aiding platelet activation, aggregation, and fibrin clot formation. | Drug | TXA+Sealant |
| 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 | TXA, TXA+Sealant |
Primary outcome
Serum Hb
Time frame: Preoperatively and one day after surgery
Serum Haemoglobin (g/dL)
Knee Flexion ROM
Time frame: Preoperatively and one day after surgery
Knee flexion range of motion (°)
Ambulation Distance
Time frame: One day after surgery
Ambulation distance (m)
Rest Pain Score
Time frame: One day after surgery
Rest pain visual analogue scales (VAS) between 0 (no pain) and 10 (worst pain)
Ambulatory Pain Score
Time frame: One day after surgery
Ambulatory pain visual analogue scales (VAS) between 0 (no pain) and 10 (worst pain)
3 secondary outcomes
PROMs - OKS
Time frame: Pre-operatively and 6 months post-operatively
PROMs - AKSS
Time frame: 6 months post-operatively
PROMs - SF-36
Time frame: 6 months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 38138181Liu 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.
- Background: PubMed 27773860Li 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.
- Background: PubMed 27317900Gao 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.
- Background: PubMed 29916929Abdel 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.
- Individual participant dataSharing planned: No. Data collected solely as part of this study will not be shared or used for alternative study purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Han Lincoln Liow principal investigator
Singapore General Hospital
Azmi Rahman principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fibrin sealant and Tranexamic Acid (TXA) in people with Osteo Arthritis of the Knee, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Hb (time frame: Preoperatively and one day after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07455591, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.