| CTRI Number |
CTRI/2025/01/079383 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomised control trial comparing haemostatic effect of Oxidised Regenerated
Cellulose versus Intravenous Tranexamic Acid
in Total Knee Arthroplasty |
|
Scientific Title of Study
|
Haemostatic effect of Oxidised Regenerated
Cellulose versus Intravenous Tranexamic Acid
in Total Knee Arthroplasty: A Randomised
Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roop Bhushan Kalia |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Orthopaedics
6th floor
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8518881790 |
| Fax |
|
| Email |
roop.orth@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Roop Bhushan Kalia |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Orthopaedics
6th floor
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8518881790 |
| Fax |
|
| Email |
roop.orth@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Aritra Chattopadhyay |
| Designation |
Senior Resident Orthopaedics |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Orthopaedics
6th Floor
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
08910600769 |
| Fax |
|
| Email |
achat96@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rishikesh
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India |
|
|
Primary Sponsor
|
| Name |
Aritra Chattopadhyay |
| Address |
Department of Orthopaedics
6th floor
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aritra Chattopadhyay |
AIIMS Rishikesh |
Department of Orthopaedics, 6th Floor
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India
Dehradun
UTTARANCHAL |
08910600769
achat96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oxidised Regenerated Cellulose |
2 sheets of Oxidised Regenerated Cellulose 5.1 x 7.6 cm intraarticularly prior to closure intraoperatively |
| Comparator Agent |
Tranexamic acid |
15mg/kg Tranexamic acid Intravenously 10 mins before tourniquet inflation intraoperatively single dose |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing bilateral total knee arthroplasty for bilateral primary osteoarthritis of knee |
|
| ExclusionCriteria |
| Details |
1. Preoperative anaemia
2. Inflammatory arthritis
3. Arterial or venous thromboembolic diseases
4. Cerebrovascular diseases; hepatic, renal, cardiac dysfunction
5. Genu varum, genu valgum or flexion contracture greater than thirty degrees
6. Congenital or acquired coagulation disorders
7. Intra-op complications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Blood loss |
Postop day3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative Blood loss |
Calculated immediately after surgery is finished |
| Hidden Blood loss |
Postop day 3 |
| Drain output |
Postop day 3 |
| KOOS-JR score |
2 and 6 weeks followup |
| Knee Range of Motion |
2 and 6 weeks followup |
| ESR,CRP,Fibrinogen,D-dimer,PT/INR |
Preoperatively and at postop day 1 and 3 |
| Reported complication/readmission |
6 weeks followup |
| Surgical time |
Calculated immediately after surgery is finished |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Total knee arthroplasty (TKA) stands as a time-tested intervention for addressing
end-stage knee degenerative arthritis with excellent results. Despite its generally
acknowledged safety, TKA procedures may lead to considerable perioperative blood
loss, reaching up to 1500 mL. This substantial blood loss can necessitate blood
transfusions, posing risks of periprosthetic infection and adverse hypersensitivity
reactions, susceptibility to blood-borne diseases and immune-related disorders,
while also potentially leading to various complications including lung injury, renal
failure, and coagulation abnormalities. Consequently, minimizing blood loss
following TKA emerges as a pivotal factor in enhancing patients’ postoperative
recovery and rehabilitation. Moreover, excessive blood loss among TKA patients
escalates both the economic strain on healthcare systems and individuals due to
increased transfusion needs and prolonged hospital stays. Oxidized regenerated cellulose (ORC) represents a form of biodegradable topical
haemostatic material. Yackel et al. first synthesized and investigated oxidized
cellulose in 1942, revealing its plant-derived nature and highlighting its safety, ease
of application, and clinical efficacy. Presently, ORC finds widespread utilization as
an absorbable haemostatic agent across various medical domains such as
neurosurgery, thoracic surgery, general surgery, urology, and gynaecology. Even though the adoption of ORC in orthopaedic contexts and arthroplasty remains
relatively limited, previous studies have demonstrated that ORC can effectively
reduce the total blood loss and hidden blood loss of patients after total knee arthroplasty under the premise of ensuring safety, and avoid transfusion due to
excessive blood loss. Tranexamic acid (TXA), functioning as an antifibrinolytic agent, enjoys broad
acknowledgment for its safety and efficacy in mitigating blood loss during TKA
procedures. Although contemporary guidelines advocate for the standardized
incorporation of TXA in TKA protocols, debates persist regarding the optimal dosage
and administration route. Network meta-analysis have shown low-dose
intravenous, high-dose intravenous, low-dose topical, high-dose topical and oral TXA
as well as combinations of intravenous/topical and intravenous/ oral TXA to reduce
blood loss and risk of transfusion during the perioperative episode of a TKA and no
clear superior method or combination of methods. However, Contraindications that
limit the use of TXA include a history of a thromboembolic or ischemic event such as
PE, DVT, ischemic cerebrovascular accident, acute myocardial infarction, or
ischemic retinopathy. Moreover, within the existing literature, while numerous
investigators have affirmed the efficacy of TXA in diminishing visible blood loss, there
remains contention regarding its impact on hidden blood loss. Certain studies
have indicated that TXA administration in knee replacement cases leads to a
reduction in external blood loss while failing to affect hidden blood loss. Our study aims to compare the clinical efficacy with regards to total and hidden blood
loss reduction after total knee arthroplasty as well as safety between ORC and
tranexamic acid, aiming to provide a safer and more effective haemostatic solution
for patients with or without contraindications to tranexamic acid usage
Null Hypothesis: Haemostatic effect of Oxidised Regenerated Cellulose is inferior
to IV Tranexamic acid when used in TKA by a clinically relevant amount |