An observational study in Knee Osteoarthritis, sponsored by Tian Hua. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Tian Hua · Observational
Through this cohort study, previous clinical data can be systematically reviewed and supplemented through clinical follow-up. Prospective enrollment and follow-up observation of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The intraoperative, perioperative, clinical follow-up and health economics of surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA were comprehensively and objectively compared, the results and conclusions of the center were summarized and reported, and the effectiveness and safety of digital assistive technology applied to TKA were explored, providing references for clinical diagnosis and follow-up research.
Through this cohort study, previous clinical data can be systematically reviewed and supplemented by follow-up visits. Prospective enrollment and follow-up of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The preoperative situation (general statistical information, educational level, preoperative clinical function score, etc.), intraoperative situation (operative time, intraoperative blood loss, intraoperative complications, etc.), perioperative situation (total postoperative blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up situation were comprehensively and objectively compared with surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA We summarized and reported the results and conclusions of the center (postoperative force line, implant location, pain, mobility, clinical function score, patient satisfaction and postoperative complications, etc.) and health economics (average length of stay, hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up research.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 12,000 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →This is the only study on the registry with Tian Hua as lead sponsor.
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Patients undergoing knee replacement in our hospital
Exclusion Criteria:
Conventional instrument-assisted knee arthroplasty
Procedure: conventional intrumentation assisted knee arthroplasty
computer navigation assisted knee arthroplasty
Procedure: computer navigation assisted knee arthroplasty
robotic system assisted knee arthroplasty
Procedure: robotic system assisted knee arthroplasty
patient-spercific instrumentation assisted knee arthroplasty
Procedure: patient-spercific assisted knee arthroplasty
conventional intrumentation assisted knee arthroplasty
computer navigation assisted knee arthroplasty
robotic system assisted knee arthroplasty
patient-spercific assisted knee arthroplasty
mechanical axis
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.
Time frame: Postoperative day 3
operation time
The surgical time is defined as the time from incision to the completion of the skin suture, accurate to minutes
Time frame: immediately after the surgery
Intraoperative blood loss
Intraoperative blood loss = total amount of fluid drawn during the operation - intraoperative irrigation volume + intraoperative gauze infiltration blood loss, accurate to ml
Time frame: immediately after the surgery
Intraoperative complications
Various complications occurred during the operation were recorded
Time frame: immediately after the surgery
Total postoperative blood loss
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;
Time frame: Postoperative day 3
Blood transfusion rate
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.
Time frame: At discharge
Postoperative complication
The postoperative complications such as wound nonunion, wound infection, hematomas and anemia were recorded.
Time frame: 3 years postoperatively
Rotation Angle of femur prosthesis
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
Time frame: Postoperative day 3
Visual analogue scale
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.
Time frame: Postoperative day 3
Visual analogue scale
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.
Time frame: 2 weeks postoperatively
Visual analogue scale
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.
Time frame: 6 weeks postoperatively
Visual analogue scale
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.
Time frame: 3 months postoperatively
Visual analogue scale
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.
Time frame: 6 months postoperatively
Visual analogue scale
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.
Time frame: 12 months postoperatively
Visual analogue scale
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.
Time frame: 24 months postoperatively
Visual analogue scale
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.
Time frame: 36 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Time frame: 3 days postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Time frame: 2 weeks postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Time frame: 6 weeks postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Time frame: 3 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Time frame: 6 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Time frame: 12 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Time frame: 24 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Time frame: 36 months postoperatively
knee society score
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.
Time frame: 6 weeks postoperatively
knee society score
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.
Time frame: 3 months postoperatively
knee society score
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.
Time frame: 6 months postoperatively
knee society score
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.
Time frame: 12 months postoperatively
knee society score
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.
Time frame: 24 months postoperatively
knee society score
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.
Time frame: 36 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
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.
Time frame: 6 weeks postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
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.
Time frame: 3 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
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.
Time frame: 6 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
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.
Time frame: 12 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
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.
Time frame: 24 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
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.
Time frame: 36 months postoperatively
Patient satisfaction
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
Time frame: 6 months postoperatively
Patient satisfaction
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
Time frame: 12 months postoperatively
Patient satisfaction
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
Time frame: 24 months postoperatively
Patient satisfaction
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
Time frame: 36 months postoperatively
Length of stay
The number of days a patient stays in hospital from admission to discharge
Time frame: an average of 3 days postoperatively
Medical expenses
The total cost of a patient from admission to discharge
Time frame: an average of 3 days postoperatively
Plan to share: Yes — It will be published as an academic paper
Supporting information: Study protocol, Csr
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