Knee OsteoarthritisPhase 4NCT06608992
Evaluation of the Effect of SURGICEL® Powder in TKA
A Phase 4 study testing SURGICEL® Powder in people with Knee Osteoarthritis, run by Peking University Third Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- SURGICEL® Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2024to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with primary knee osteoarthritis based on symptoms, physical examination, and imaging, with X-ray showing Kellgren-Lawrence (K-L) stage III or higher.
- Severe knee pain with functional limitations, unresponsive to conservative treatment, and scheduled for unilateral primary total knee arthroplasty (TKA).
- No severe knee deformity (flexion deformity >30°, varus >20°, or valgus >10°).
- Patients undergoing manual surgery with traditional instruments.
Who cannot join
- 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).
- Patients undergoing TKA surgery with the assistance of robotic or navigation digital technology.
- Presence of other contraindications to total knee arthroplasty, such as metal allergies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100181
Hua Tian, doctor, 86-18811185091, tianhua@bjmu.edu.cn
Guo Wei Zhang, bachelor, 86-18811778038, 2011210412@pku.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- SURGICEL® Powder
- Keywords
- total knee arthroplasty, knee osteoarthritis, SURGICEL® Powder, the safety and hemostatic effectiveness
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURGICEL® PowderDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| using SURGICEL® Powder | Experimental | 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. Receives: Drug: SURGICEL® Powder |
| not using SURGICEL® Powder | No intervention | The SURGICEL® Powder will not be used during the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
total perioperative blood loss
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.
Measured: 1 day after surgery
total perioperative blood loss
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.
Measured: 2 days after surgery
total perioperative blood loss
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.
Measured: 3 days after surgery
total perioperative blood loss
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.
Measured: 4 days after surgery
total perioperative blood loss
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.
Measured: 5 days after surgery
Secondary outcomes (27)
pain visual analogue scale score
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Measured: 1 day after surgery
pain visual analogue scale score
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Measured: 2 days after surgery
pain visual analogue scale score
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Measured: 3 days after surgery
pain visual analogue scale score
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Measured: 4 days after surgery
pain visual analogue scale score
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Measured: 5 days after surgery
pain visual analogue scale score
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Measured: 2 weeks after surgery
Limb Swelling Rate
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Measured: Postoperative day 1
Limb Swelling Rate
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Measured: Postoperative day 2
Limb Swelling Rate
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Measured: Postoperative day 3
Limb Swelling Rate
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Measured: Postoperative day 4
Limb Swelling Rate
(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Measured: Postoperative day 5
Coagulation Testing
Assay index including D-dimers and Activated partial thromboplastin time.
Measured: Postoperative day 1
Coagulation Testing
Assay index including D-dimers and Activated partial thromboplastin time.
Measured: Postoperative day 2
Coagulation Testing
Assay index including D-dimers and Activated partial thromboplastin time.
Measured: Postoperative day 3
Coagulation Testing
Assay index including D-dimers and Activated partial thromboplastin time.
Measured: Postoperative day 4
Coagulation Testing
Assay index including D-dimers and Activated partial thromboplastin time.
Measured: Postoperative day 5
Knee range of motion
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Measured: Postoperative day 1
Knee range of motion
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Measured: Postoperative day 2
Knee range of motion
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Measured: Postoperative day 3
Knee range of motion
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Measured: Postoperative day 4
Knee range of motion
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Measured: Postoperative day 5
Knee range of motion
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Measured: Postoperative day 14
Blood routine
Assay index including white blood cell count and neutrophil count.
Measured: Postoperative day 1
Blood routine
Assay index including white blood cell count and neutrophil count.
Measured: Postoperative day 2
Blood routine
Assay index including white blood cell count and neutrophil count.
Measured: Postoperative day 3
Blood routine
Assay index including white blood cell count and neutrophil count.
Measured: Postoperative day 4
Blood routine
Assay index including white blood cell count and neutrophil count.
Measured: Postoperative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start28 Sep 2024
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Model description
- According to the inclusion/exclusion criteria for study participants, patients undergoing unilateral primary total knee arthroplasty will be screened. After obtaining informed consent from the patients, computer-based randomization will be conducted. The patients included in the study will be randomly assigned to either the test group (using SURGICEL® Powder ) or the control group (not using SURGICEL® Powder ).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hua Tian, doctor, Study chair, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608992
- Sponsor's protocol ID
- SP-TKA-RCT
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Hemostatic Effectiveness of SURGICEL® Powder in TKA：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06608992
- Acronym / sponsor ID
- SP-TKA-RCT
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, knee osteoarthritis, SURGICEL® Powder, the safety and hemostatic effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 Sep 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- According to the inclusion/exclusion criteria for study participants, patients undergoing unilateral primary total knee arthroplasty will be screened. After obtaining informed consent from the patients, computer-based randomization will be conducted. The patients included in the study will be randomly assigned to either the test group (using SURGICEL® Powder ) or the control group (not using SURGICEL® Powder ).
| Arm | Type | Receives |
|---|---|---|
| using SURGICEL® Powder | Experimental | Drug: SURGICEL® PowderThe 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. |
| not using SURGICEL® Powder | No intervention | –The SURGICEL® Powder will not be used during the surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with primary knee osteoarthritis based on symptoms, physical examination, and imaging, with X-ray showing Kellgren-Lawrence (K-L) stage III or higher.
- Severe knee pain with functional limitations, unresponsive to conservative treatment, and scheduled for unilateral primary total knee arthroplasty (TKA).
- No severe knee deformity (flexion deformity >30°, varus >20°, or valgus >10°).
- Patients undergoing manual surgery with traditional instruments.
Key exclusion criteria (3 listed)
- 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).
- Patients undergoing TKA surgery with the assistance of robotic or navigation digital technology.
- Presence of other contraindications to total knee arthroplasty, such as metal allergies.
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 |
|---|---|---|
| SURGICEL® PowderSURGICEL® 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. | Drug | using SURGICEL® Powder |
Primary outcome
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.
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.
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.
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.
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.
27 secondary outcomes
pain visual analogue scale score
Time frame: 1 day after surgery
pain visual analogue scale score
Time frame: 2 days after surgery
pain visual analogue scale score
Time frame: 3 days after surgery
pain visual analogue scale score
Time frame: 4 days after surgery
pain visual analogue scale score
Time frame: 5 days after surgery
pain visual analogue scale score
Time frame: 2 weeks after surgery
Limb Swelling Rate
Time frame: Postoperative day 1
Limb Swelling Rate
Time frame: Postoperative day 2
Limb Swelling Rate
Time frame: Postoperative day 3
Limb Swelling Rate
Time frame: Postoperative day 4
Limb Swelling Rate
Time frame: Postoperative day 5
Coagulation Testing
Time frame: Postoperative day 1
Coagulation Testing
Time frame: Postoperative day 2
Coagulation Testing
Time frame: Postoperative day 3
Coagulation Testing
Time frame: Postoperative day 4
Coagulation Testing
Time frame: Postoperative day 5
Knee range of motion
Time frame: Postoperative day 1
Knee range of motion
Time frame: Postoperative day 2
Knee range of motion
Time frame: Postoperative day 3
Knee range of motion
Time frame: Postoperative day 4
Knee range of motion
Time frame: Postoperative day 5
Knee range of motion
Time frame: Postoperative day 14
Blood routine
Time frame: Postoperative day 1
Blood routine
Time frame: Postoperative day 2
Blood routine
Time frame: Postoperative day 3
Blood routine
Time frame: Postoperative day 4
Blood routine
Time frame: Postoperative day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Hua Tian, doctor study chair
Director
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 SURGICEL® Powder in people with Knee Osteoarthritis, run by Peking University Third Hospital at 1 site in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Feb 2025. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Tian, doctor (86-18811185091, tianhua@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total perioperative blood loss (time frame: 1 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?
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 12 Feb 2025.