- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06010979
Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tian Hua, MD
- Phone Number: 86-13511065187
- Email: tianhua@bjmu.edu.cn
Study Contact Backup
- Name: Zheng Yuhang, MD
- Phone Number: 86-18811185091
- Email: 1710301104@pku.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100181
- Recruiting
- Peking University Third Hospital
-
Contact:
- Zheng Yuhang, bachelor
- Phone Number: 86-18811185091
- Email: 1710301104@pku.edu.cn
-
Contact:
- Tian Hua, MD
- Phone Number: 86-18211070116
- Email: tianhua@bjmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- a. primary knee osteoarthritis;
- b. Unilateral primary knee replacement;
- c. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide
Exclusion Criteria:
- a. A history of renal insufficiency (Cr > 2.5), liver insufficiency, severe heart disease (or coronary stenting within the last 12 months), severe respiratory disease, history of VTE or high risk of thrombosis (hereditary/acquired thrombotic disease), cotting disorder, stroke, and malignancy;
- b. Those who do not accept this test for any reason and refuse to sign the informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
conventional group
Conventional instrument-assisted knee arthroplasty
|
conventional intrumentation assisted knee arthroplasty
|
CAS group
computer navigation assisted knee arthroplasty
|
computer navigation assisted knee arthroplasty
|
RAS group
robotic system assisted knee arthroplasty
|
robotic system assisted knee arthroplasty
|
PSI group
patient-spercific instrumentation assisted knee arthroplasty
|
patient-spercific assisted knee arthroplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mechanical axis
Time Frame: Postoperative day 3
|
The postoperative HKA Angle was measured, that is, the Angle between the center of the hip joint and the center of the knee joint and the center of the knee joint and the center of the ankle joint on the full-length X-ray film of the lower limb.
The target Angle was defined as 0°, the Angle was positive when the knee was varus, the Angle was negative when the knee was varus, and the acceptable range was ±3°, beyond which the line deviation was defined.
|
Postoperative day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
operation time
Time Frame: immediately after the surgery
|
The surgical time is defined as the time from incision to the completion of the skin suture, accurate to minutes
|
immediately after the surgery
|
Intraoperative blood loss
Time Frame: immediately after the surgery
|
Intraoperative blood loss = total amount of fluid drawn during the operation - intraoperative irrigation volume + intraoperative gauze infiltration blood loss, accurate to ml
|
immediately after the surgery
|
Intraoperative complications
Time Frame: immediately after the surgery
|
Various complications occurred during the operation were recorded
|
immediately after the surgery
|
Total postoperative blood loss
Time Frame: Postoperative day 3
|
Gross linear equation was used to calculate total blood loss and latent blood loss 3 days after surgery.
Total blood loss = preoperative blood volume (PBV) × (preoperative hematocrit - postoperative hematocrit).
PBV was calculated using Nadler method: PBV=K1× height (m) 3+K2× weight (kg) +K3, where male K1=0.3669,
K2=0.03219,
K3=0.6041;
Female K1=0.3561,
K2=0.03308,
K3=0.1833.
Postoperative total blood loss = total blood loss - intraoperative blood loss;
|
Postoperative day 3
|
Blood transfusion rate
Time Frame: At discharge
|
The postoperative blood transfusion situation and the amount of blood transfusion were recorded. The blood was transfused mainly with suspended red blood cells, and the amount of a single transfusion was 400ml. The Hb situation was evaluated again by blood routine review on the morning of the second day after transfusion. Indications for postoperative blood transfusion: No blood transfusion for Hb up to 8g/L or above; Hb up to 7g/L (including) must be transfused; Hb is between 7-8g/L, and blood transfusion should be given when anemia symptoms such as dizziness, weakness, palpitation, etc. |
At discharge
|
Postoperative complication
Time Frame: 3 years postoperatively
|
The postoperative complications such as wound nonunion, wound infection, hematomas and anemia were recorded.
|
3 years postoperatively
|
Rotation Angle of femur prosthesis
Time Frame: Postoperative day 3
|
On the horizontal plane of CT scan of the affected knee, the Angle between the line of the posterior condyle of the femoral prosthesis and the line of the transcondyle of the femur was shown.
The target Angle was defined as 0° external rotation of the femoral prosthesis, positive Angle during external rotation, negative Angle during internal rotation, acceptable range of ±2°, beyond which was defined as angular deviation
|
Postoperative day 3
|
Visual analogue scale
Time Frame: Postoperative day 3
|
The pain of the affected limb was assessed by Visual analogue scale.
The highest score is ten and the lowest score is zero.
A higher score indicates a higher level of pain.
|
Postoperative day 3
|
Visual analogue scale
Time Frame: 2 weeks postoperatively
|
The pain of the affected limb was assessed by Visual analogue scale.
The highest score is ten and the lowest score is zero.
A higher score indicates a higher level of pain.
|
2 weeks postoperatively
|
Visual analogue scale
Time Frame: 6 weeks postoperatively
|
The pain of the affected limb was assessed by Visual analogue scale.
The highest score is ten and the lowest score is zero.
A higher score indicates a higher level of pain.
|
6 weeks postoperatively
|
Visual analogue scale
Time Frame: 3 months postoperatively
|
The pain of the affected limb was assessed by Visual analogue scale.
The highest score is ten and the lowest score is zero.
A higher score indicates a higher level of pain.
|
3 months postoperatively
|
Visual analogue scale
Time Frame: 6 months postoperatively
|
The pain of the affected limb was assessed by Visual analogue scale.
The highest score is ten and the lowest score is zero.
A higher score indicates a higher level of pain.
|
6 months postoperatively
|
Visual analogue scale
Time Frame: 12 months postoperatively
|
The pain of the affected limb was assessed by Visual analogue scale.
The highest score is ten and the lowest score is zero.
A higher score indicates a higher level of pain.
|
12 months postoperatively
|
Visual analogue scale
Time Frame: 24 months postoperatively
|
The pain of the affected limb was assessed by Visual analogue scale.
The highest score is ten and the lowest score is zero.
A higher score indicates a higher level of pain.
|
24 months postoperatively
|
Visual analogue scale
Time Frame: 36 months postoperatively
|
The pain of the affected limb was assessed by Visual analogue scale.
The highest score is ten and the lowest score is zero.
A higher score indicates a higher level of pain.
|
36 months postoperatively
|
Range of motion
Time Frame: 3 days postoperatively
|
The Range of motion of the knee on the operative side of the patient was measured
|
3 days postoperatively
|
Range of motion
Time Frame: 2 weeks postoperatively
|
The Range of motion of the knee on the operative side of the patient was measured
|
2 weeks postoperatively
|
Range of motion
Time Frame: 6 weeks postoperatively
|
The Range of motion of the knee on the operative side of the patient was measured
|
6 weeks postoperatively
|
Range of motion
Time Frame: 3 months postoperatively
|
The Range of motion of the knee on the operative side of the patient was measured
|
3 months postoperatively
|
Range of motion
Time Frame: 6 months postoperatively
|
The Range of motion of the knee on the operative side of the patient was measured
|
6 months postoperatively
|
Range of motion
Time Frame: 12 months postoperatively
|
The Range of motion of the knee on the operative side of the patient was measured
|
12 months postoperatively
|
Range of motion
Time Frame: 24 months postoperatively
|
The Range of motion of the knee on the operative side of the patient was measured
|
24 months postoperatively
|
Range of motion
Time Frame: 36 months postoperatively
|
The Range of motion of the knee on the operative side of the patient was measured
|
36 months postoperatively
|
knee society score
Time Frame: 6 weeks postoperatively
|
This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery.
Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS.
The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively.
The higher the value, the better the function.
|
6 weeks postoperatively
|
knee society score
Time Frame: 3 months postoperatively
|
This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery.
Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS.
The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively.
The higher the value, the better the function.
|
3 months postoperatively
|
knee society score
Time Frame: 6 months postoperatively
|
This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery.
Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS.
The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively.
The higher the value, the better the function.
|
6 months postoperatively
|
knee society score
Time Frame: 12 months postoperatively
|
This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery.
Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS.
The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively.
The higher the value, the better the function.
|
12 months postoperatively
|
knee society score
Time Frame: 24 months postoperatively
|
This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery.
Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS.
The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively.
The higher the value, the better the function.
|
24 months postoperatively
|
knee society score
Time Frame: 36 months postoperatively
|
This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery.
Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS.
The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively.
The higher the value, the better the function.
|
36 months postoperatively
|
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 6 weeks postoperatively
|
This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms.
The structure and function of the knee joint were evaluated by pain, stiffness and joint function.
A higher score indicates better functionality.
|
6 weeks postoperatively
|
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 3 months postoperatively
|
This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms.
The structure and function of the knee joint were evaluated by pain, stiffness and joint function.
A higher score indicates better functionality.
|
3 months postoperatively
|
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 6 months postoperatively
|
This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms.
The structure and function of the knee joint were evaluated by pain, stiffness and joint function.
A higher score indicates better functionality.
|
6 months postoperatively
|
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 12 months postoperatively
|
This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms.
The structure and function of the knee joint were evaluated by pain, stiffness and joint function.
A higher score indicates better functionality.
|
12 months postoperatively
|
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 24 months postoperatively
|
This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms.
The structure and function of the knee joint were evaluated by pain, stiffness and joint function.
A higher score indicates better functionality.
|
24 months postoperatively
|
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 36 months postoperatively
|
This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms.
The structure and function of the knee joint were evaluated by pain, stiffness and joint function.
A higher score indicates better functionality.
|
36 months postoperatively
|
Patient satisfaction
Time Frame: 6 months postoperatively
|
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale).
The higher the score, the higher the satisfaction
|
6 months postoperatively
|
Patient satisfaction
Time Frame: 12 months postoperatively
|
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale).
The higher the score, the higher the satisfaction
|
12 months postoperatively
|
Patient satisfaction
Time Frame: 24 months postoperatively
|
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale).
The higher the score, the higher the satisfaction
|
24 months postoperatively
|
Patient satisfaction
Time Frame: 36 months postoperatively
|
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale).
The higher the score, the higher the satisfaction
|
36 months postoperatively
|
Length of stay
Time Frame: an average of 3 days postoperatively
|
The number of days a patient stays in hospital from admission to discharge
|
an average of 3 days postoperatively
|
Medical expenses
Time Frame: an average of 3 days postoperatively
|
The total cost of a patient from admission to discharge
|
an average of 3 days postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tian Hua, MD, Director
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TKAcohort
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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