Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

Sponsor

Tian Hua (Other)

Overall Status

Recruiting

CT.gov ID

NCT06010979

Collaborator

(none)

12,000

Enrollment

Location

Anticipated Duration (Months)

333.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Procedure: conventional intrumentation assisted knee arthroplasty Procedure: computer navigation assisted knee arthroplasty Procedure: robotic system assisted knee arthroplasty Procedure: patient-spercific assisted knee arthroplasty

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

12000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
conventional group Conventional instrument-assisted knee arthroplasty	Procedure: conventional intrumentation assisted knee arthroplasty conventional intrumentation assisted knee arthroplasty
CAS group computer navigation assisted knee arthroplasty	Procedure: computer navigation assisted knee arthroplasty computer navigation assisted knee arthroplasty
RAS group robotic system assisted knee arthroplasty	Procedure: robotic system assisted knee arthroplasty robotic system assisted knee arthroplasty
PSI group patient-spercific instrumentation assisted knee arthroplasty	Procedure: patient-spercific assisted knee arthroplasty patient-spercific assisted knee arthroplasty

Outcome Measures

Primary Outcome Measures

mechanical axis [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.

Secondary Outcome Measures

operation time [immediately after the surgery]
The surgical time is defined as the time from incision to the completion of the skin suture, accurate to minutes
Intraoperative blood loss [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
Intraoperative complications [immediately after the surgery]
Various complications occurred during the operation were recorded
Total postoperative blood loss [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;
Blood transfusion rate [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.
Postoperative complication [3 years postoperatively]
The postoperative complications such as wound nonunion, wound infection, hematomas and anemia were recorded.
Rotation Angle of femur prosthesis [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
Visual analogue scale [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.
Visual analogue scale [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.
Visual analogue scale [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.
Visual analogue scale [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.
Visual analogue scale [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.
Visual analogue scale [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.
Visual analogue scale [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.
Visual analogue scale [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.
Range of motion [3 days postoperatively]
The Range of motion of the knee on the operative side of the patient was measured
Range of motion [2 weeks postoperatively]
The Range of motion of the knee on the operative side of the patient was measured
Range of motion [6 weeks postoperatively]
The Range of motion of the knee on the operative side of the patient was measured
Range of motion [3 months postoperatively]
The Range of motion of the knee on the operative side of the patient was measured
Range of motion [6 months postoperatively]
The Range of motion of the knee on the operative side of the patient was measured
Range of motion [12 months postoperatively]
The Range of motion of the knee on the operative side of the patient was measured
Range of motion [24 months postoperatively]
The Range of motion of the knee on the operative side of the patient was measured
Range of motion [36 months postoperatively]
The Range of motion of the knee on the operative side of the patient was measured
knee society score [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.
knee society score [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.
knee society score [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.
knee society score [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.
knee society score [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.
knee society score [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.
Western Ontario and McMaster Universities Osteoarthritis Index [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.
Western Ontario and McMaster Universities Osteoarthritis Index [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.
Western Ontario and McMaster Universities Osteoarthritis Index [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.
Western Ontario and McMaster Universities Osteoarthritis Index [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.
Western Ontario and McMaster Universities Osteoarthritis Index [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.
Western Ontario and McMaster Universities Osteoarthritis Index [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.
Patient satisfaction [6 months postoperatively]
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
Patient satisfaction [12 months postoperatively]
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
Patient satisfaction [24 months postoperatively]
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
Patient satisfaction [36 months postoperatively]
At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
Length of stay [an average of 3 days postoperatively]
The number of days a patient stays in hospital from admission to discharge
Medical expenses [an average of 3 days postoperatively]
The total cost of a patient from admission to discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. primary knee osteoarthritis;
1. Unilateral primary knee replacement;
1. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide

Exclusion Criteria:

1. 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;
1. Those who do not accept this test for any reason and refuse to sign the informed consent.