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NCT Number: NCT06010979

Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conventional intrumentation 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 assisted knee arthroplasty

Procedure

patient-spercific assisted knee arthroplasty

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Intraoperative complications

    Time frame: immediately after the surgery

    Various complications occurred during the operation were recorded

  4. 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;

  5. 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.

  6. Postoperative complication

    Time frame: 3 years postoperatively

    The postoperative complications such as wound nonunion, wound infection, hematomas and anemia were recorded.

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Range of motion

    Time frame: 3 days postoperatively

    The Range of motion of the knee on the operative side of the patient was measured

  17. Range of motion

    Time frame: 2 weeks postoperatively

    The Range of motion of the knee on the operative side of the patient was measured

  18. Range of motion

    Time frame: 6 weeks postoperatively

    The Range of motion of the knee on the operative side of the patient was measured

  19. Range of motion

    Time frame: 3 months postoperatively

    The Range of motion of the knee on the operative side of the patient was measured

  20. Range of motion

    Time frame: 6 months postoperatively

    The Range of motion of the knee on the operative side of the patient was measured

  21. Range of motion

    Time frame: 12 months postoperatively

    The Range of motion of the knee on the operative side of the patient was measured

  22. Range of motion

    Time frame: 24 months postoperatively

    The Range of motion of the knee on the operative side of the patient was measured

  23. Range of motion

    Time frame: 36 months postoperatively

    The Range of motion of the knee on the operative side of the patient was measured

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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. 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

  37. 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

  38. 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

  39. 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

  40. Length of stay

    Time frame: an average of 3 days postoperatively

    The number of days a patient stays in hospital from admission to discharge

  41. Medical expenses

    Time frame: an average of 3 days postoperatively

    The total cost of a patient from admission to discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Tian Hua, MD

CONTACT

[email protected]

86-13511065187

Zheng Yuhang, MD

CONTACT

[email protected]

86-18811185091

Sponsors and collaborators

Lead sponsor

Tian Hua

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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