Evaluation of the Effect of SURGICEL® Powder in TKA

February 10, 2025 updated by: Peking University Third Hospital

Evaluation of the Safety and Hemostatic Effectiveness of SURGICEL® Powder in TKA：a Randomized Controlled Trial

The study subjects are patients in our hospital's orthopedics department undergoing unilateral primary total knee arthroplasty (TKA) due to primary osteoarthritis. Through a prospective, parallel randomized controlled study, 112 participants will be divided into two groups: the SURGICEL® Powder group and the non-use group. The study will compare the total perioperative blood loss , intraoperative blood loss, transfusion rate and volume, postoperative hemoglobin decline, hematocrit decline, limb swelling rate , postoperative limb pain , and range of motion. Statistical analysis will be performed on the data to observe the hemostatic effects of SURGICEL® Powder, providing recommendations for the clinical use of SURGICEL® Powder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study subjects are patients in our hospital's orthopedics department undergoing unilateral primary total knee arthroplasty (TKA) due to primary osteoarthritis. Through a prospective, parallel randomized controlled study, 112 participants will be divided into two groups: the SURGICEL® Powder group and the non-use group. The study will compare the total perioperative blood loss (on postoperative days 3 and 5), intraoperative blood loss, transfusion rate and volume, postoperative hemoglobin decline, hematocrit decline, limb swelling rate (postoperative days 1-5), postoperative limb pain (measured by the Visual Analogue Scale, VAS, on days 1-5), and range of motion (ROM on days 1-5). Statistical analysis will be performed on the data to observe the hemostatic effects of SURGICEL® Powder, providing recommendations for the clinical use of SURGICEL® Powder.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100181
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with primary knee osteoarthritis based on symptoms, physical examination, and imaging, with X-ray showing Kellgren-Lawrence (K-L) stage III or higher.
  2. Severe knee pain with functional limitations, unresponsive to conservative treatment, and scheduled for unilateral primary total knee arthroplasty (TKA).
  3. No severe knee deformity (flexion deformity >30°, varus >20°, or valgus >10°).
  4. Patients undergoing manual surgery with traditional instruments.

Exclusion Criteria:

  1. History of long-term anticoagulant use for more than 3 months due to cardiovascular or cerebrovascular disease and failure to stop medication (Aspirin/Clopidogrel <7 days, Warfarin <5 days, or Reserpine <7 days), or the presence of the following conditions: renal insufficiency (blood urea nitrogen ≥25.3 mmol/L or serum creatinine ≥442 μmol/L), liver insufficiency (ALT or AST ≥80 U/L), severe heart disease (or coronary stent placement within the last 12 months), severe respiratory disease (lung function FEV1.0 <0.5L or FEV1.0/FVC <60%), history of venous thromboembolism (VTE) or high risk of thrombosis (hereditary/acquired thrombotic disorders), coagulation disorders (APTT ≥46 seconds or INR ≥1.7), stroke, or history of malignant tumors; anemia (according to WHO anemia diagnosis criteria, Hb <130 g/L for males and <120 g/L for females).
  2. Patients undergoing TKA surgery with the assistance of robotic or navigation digital technology.
  3. Presence of other contraindications to total knee arthroplasty, such as metal allergies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: using SURGICEL® Powder
The SURGICEL® Powder will be sprayed in areas such as the posterior joint capsule, medial gap, lateral gap, suprapatellar pouch, and infrapatellar fat pad. After the SURGICEL® Powder fully react and change color, any unreacted SURGICEL® Powder will be appropriately washed using an irrigation gun.
Drug: SURGICEL® Powder
SURGICEL® Powder are hemostatic product made of compacted, regenerated oxidized cellulose fine fiber aggregates, produced using a patented process. These particles are pre-loaded into an applicator device for application to the target bleeding site. SURGICEL® Powder are white with a slight yellow tint and have a faint caramel-like scent.When SURGICEL® Powder are fully saturated with blood, they expand into a brown or black gel-like substance that helps form a blood clot. This substance acts as a hemostatic adjunct to control localized bleeding.
No Intervention: not using SURGICEL® Powder
The SURGICEL® Powder will not be used during the surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
total perioperative blood loss
Time Frame: 1 day after surgery

Total Blood Loss = Preoperative Blood Volume (PBV) × (Preoperative Hematocrit - Postoperative Hematocrit) / Average Hematocrit + Transfusion Volume

Where:

Average Hematocrit = (Preoperative Hematocrit + Postoperative Hematocrit) / 2

PBV is calculated using Nadler's method:

PBV = K1 × Height (m)³ + K2 × Weight (kg) + K3 For males: K1 = 0.3669, K2 = 0.03219, K3 = 0.6041 For females: K1 = 0.3561, K2 = 0.03308, K3 = 0.1833；The lower it is, the better the hemostatic effect.
1 day after surgery
total perioperative blood loss
Time Frame: 2 days after surgery

Total Blood Loss = Preoperative Blood Volume (PBV) × (Preoperative Hematocrit - Postoperative Hematocrit) / Average Hematocrit + Transfusion Volume

Where:

Average Hematocrit = (Preoperative Hematocrit + Postoperative Hematocrit) / 2

PBV is calculated using Nadler's method:

PBV = K1 × Height (m)³ + K2 × Weight (kg) + K3 For males: K1 = 0.3669, K2 = 0.03219, K3 = 0.6041 For females: K1 = 0.3561, K2 = 0.03308, K3 = 0.1833；The lower it is, the better the hemostatic effect.
2 days after surgery
total perioperative blood loss
Time Frame: 3 days after surgery

Total Blood Loss = Preoperative Blood Volume (PBV) × (Preoperative Hematocrit - Postoperative Hematocrit) / Average Hematocrit + Transfusion Volume

Where:

Average Hematocrit = (Preoperative Hematocrit + Postoperative Hematocrit) / 2

PBV is calculated using Nadler's method:

PBV = K1 × Height (m)³ + K2 × Weight (kg) + K3 For males: K1 = 0.3669, K2 = 0.03219, K3 = 0.6041 For females: K1 = 0.3561, K2 = 0.03308, K3 = 0.1833；The lower it is, the better the hemostatic effect.
3 days after surgery
total perioperative blood loss
Time Frame: 4 days after surgery

Total Blood Loss = Preoperative Blood Volume (PBV) × (Preoperative Hematocrit - Postoperative Hematocrit) / Average Hematocrit + Transfusion Volume

Where:

Average Hematocrit = (Preoperative Hematocrit + Postoperative Hematocrit) / 2

PBV is calculated using Nadler's method:

PBV = K1 × Height (m)³ + K2 × Weight (kg) + K3 For males: K1 = 0.3669, K2 = 0.03219, K3 = 0.6041 For females: K1 = 0.3561, K2 = 0.03308, K3 = 0.1833；The lower it is, the better the hemostatic effect.
4 days after surgery
total perioperative blood loss
Time Frame: 5 days after surgery

Total Blood Loss = Preoperative Blood Volume (PBV) × (Preoperative Hematocrit - Postoperative Hematocrit) / Average Hematocrit + Transfusion Volume

Where:

Average Hematocrit = (Preoperative Hematocrit + Postoperative Hematocrit) / 2

PBV is calculated using Nadler's method:

PBV = K1 × Height (m)³ + K2 × Weight (kg) + K3 For males: K1 = 0.3669, K2 = 0.03219, K3 = 0.6041 For females: K1 = 0.3561, K2 = 0.03308, K3 = 0.1833；The lower it is, the better the hemostatic effect.
5 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee range of motion
Time Frame: Postoperative day 1
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Postoperative day 1
Knee range of motion
Time Frame: Postoperative day 2
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Postoperative day 2
Knee range of motion
Time Frame: Postoperative day 3
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Postoperative day 3
pain visual analogue scale score
Time Frame: 2 weeks after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
2 weeks after surgery
Blood routine
Time Frame: Postoperative day 1
Assay index including white blood cell count and neutrophil count.
Postoperative day 1
Blood routine
Time Frame: Postoperative day 2
Assay index including white blood cell count and neutrophil count.
Postoperative day 2
Blood routine
Time Frame: Postoperative day 3
Assay index including white blood cell count and neutrophil count.
Postoperative day 3
pain visual analogue scale score
Time Frame: 1 day after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
1 day after surgery
pain visual analogue scale score
Time Frame: 2 days after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
2 days after surgery
pain visual analogue scale score
Time Frame: 3 days after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
3 days after surgery
pain visual analogue scale score
Time Frame: 4 days after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
4 days after surgery
pain visual analogue scale score
Time Frame: 5 days after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
5 days after surgery
Limb Swelling Rate
Time Frame: Postoperative day 1
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Postoperative day 1
Limb Swelling Rate
Time Frame: Postoperative day 2
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Postoperative day 2
Limb Swelling Rate
Time Frame: Postoperative day 3
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Postoperative day 3
Limb Swelling Rate
Time Frame: Postoperative day 4
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Postoperative day 4
Limb Swelling Rate
Time Frame: Postoperative day 5
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Postoperative day 5
Coagulation Testing
Time Frame: Postoperative day 1
Assay index including D-dimers and Activated partial thromboplastin time.
Postoperative day 1
Coagulation Testing
Time Frame: Postoperative day 2
Assay index including D-dimers and Activated partial thromboplastin time.
Postoperative day 2
Coagulation Testing
Time Frame: Postoperative day 3
Assay index including D-dimers and Activated partial thromboplastin time.
Postoperative day 3
Coagulation Testing
Time Frame: Postoperative day 4
Assay index including D-dimers and Activated partial thromboplastin time.
Postoperative day 4
Coagulation Testing
Time Frame: Postoperative day 5
Assay index including D-dimers and Activated partial thromboplastin time.
Postoperative day 5
Knee range of motion
Time Frame: Postoperative day 4
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Postoperative day 4
Knee range of motion
Time Frame: Postoperative day 5
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Postoperative day 5
Knee range of motion
Time Frame: Postoperative day 14
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Postoperative day 14
Blood routine
Time Frame: Postoperative day 4
Assay index including white blood cell count and neutrophil count.
Postoperative day 4
Blood routine
Time Frame: Postoperative day 5
Assay index including white blood cell count and neutrophil count.
Postoperative day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hua Tian, doctor, Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP-TKA-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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