Osteo Arthritis of the Knee
Conditions
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.
Interventions
DRUGfibrin sealant
Fibrin sealant contains human thrombin and fibrinogen, aiding platelet activation, aggregation, and fibrin clot formation.
DRUGTranexamic Acid (TXA)
Topical Tranexamic Acid (TXA) is an antifibrinolytic agent which stabilises clot formation and is infiltrated into local tissues perioperatively prior to closure.
Sponsors
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fits clinically-assessed criteria for total knee replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation Distance | One day after surgery | Ambulation distance (m) |
| Rest Pain Score | One day after surgery | Rest pain visual analogue scales (VAS) between 0 (no pain) and 10 (worst pain) |
| Serum Hb | Preoperatively and one day after surgery | Serum Haemoglobin (g/dL) |
| Knee Flexion ROM | Preoperatively and one day after surgery | Knee flexion range of motion (°) |
| Ambulatory Pain Score | One day after surgery | Ambulatory pain visual analogue scales (VAS) between 0 (no pain) and 10 (worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMs - OKS | Pre-operatively and 6 months post-operatively | Oxford Knee Score (0-48, higher is better) |
| PROMs - AKSS | 6 months post-operatively | American Knee Society Score (0-100, higher is better) |
| PROMs - SF-36 | 6 months post-operatively | SF-36 Score (0-100, higher is better) |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORMing Han Lincoln Liow
Singapore General Hospital
PRINCIPAL_INVESTIGATORAzmi Rahman
Singapore General Hospital
Outcome results
None listed