## Protocol Section
### Identification Module
**NCT ID:** NCT06010979

**Brief Title:** Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

**Official Title:** Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

#### Organization Study ID Info
**ID:** TKAcohort
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-25

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ESTIMATED

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2023-08-25
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-09
**Study First Submit QC Date:** 2023-08-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tian Hua

#### Responsible Party

**Investigator Affiliation:** Peking University Third Hospital

**Investigator Full Name:** Tian Hua

**Investigator Title:** archiater

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Knee Osteoarthritis

**Keywords:**

- total knee arthroplasty

- knee osteoarthritis

- computer navigation

- robotic system

- patient-spercific instrumentation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 12000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** Conventional instrument-assisted knee arthroplasty

**Intervention Names:**

- Procedure: conventional intrumentation assisted knee arthroplasty

**Label:** conventional group

#### Arm Group 2

**Description:** computer navigation assisted knee arthroplasty

**Intervention Names:**

- Procedure: computer navigation assisted knee arthroplasty

**Label:** CAS group

#### Arm Group 3

**Description:** robotic system assisted knee arthroplasty

**Intervention Names:**

- Procedure: robotic system assisted knee arthroplasty

**Label:** RAS group

#### Arm Group 4

**Description:** patient-spercific instrumentation assisted knee arthroplasty

**Intervention Names:**

- Procedure: patient-spercific assisted knee arthroplasty

**Label:** PSI group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- conventional group

**Description:** conventional intrumentation assisted knee arthroplasty

**Name:** conventional intrumentation assisted knee arthroplasty

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- CAS group

**Description:** computer navigation assisted knee arthroplasty

**Name:** computer navigation assisted knee arthroplasty

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- RAS group

**Description:** robotic system assisted knee arthroplasty

**Name:** robotic system assisted knee arthroplasty

**Type:** PROCEDURE

#### Intervention 4

**Arm Group Labels:**

- PSI group

**Description:** patient-spercific assisted knee arthroplasty

**Name:** patient-spercific assisted knee arthroplasty

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** mechanical axis

**Time Frame:** Postoperative day 3

#### Secondary Outcomes

**Description:** The surgical time is defined as the time from incision to the completion of the skin suture, accurate to minutes

**Measure:** operation time

**Time Frame:** immediately after the surgery

**Description:** Intraoperative blood loss = total amount of fluid drawn during the operation - intraoperative irrigation volume + intraoperative gauze infiltration blood loss, accurate to ml

**Measure:** Intraoperative blood loss

**Time Frame:** immediately after the surgery

**Description:** Various complications occurred during the operation were recorded

**Measure:** Intraoperative complications

**Time Frame:** immediately after the surgery

**Description:** 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;

**Measure:** Total postoperative blood loss

**Time Frame:** Postoperative day 3

**Description:** 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.

**Measure:** Blood transfusion rate

**Time Frame:** At discharge

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

**Measure:** Postoperative complication

**Time Frame:** 3 years postoperatively

**Description:** 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

**Measure:** Rotation Angle of femur prosthesis

**Time Frame:** Postoperative day 3

**Description:** 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.

**Measure:** Visual analogue scale

**Time Frame:** Postoperative day 3

**Description:** 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.

**Measure:** Visual analogue scale

**Time Frame:** 2 weeks postoperatively

**Description:** 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.

**Measure:** Visual analogue scale

**Time Frame:** 6 weeks postoperatively

**Description:** 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.

**Measure:** Visual analogue scale

**Time Frame:** 3 months postoperatively

**Description:** 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.

**Measure:** Visual analogue scale

**Time Frame:** 6 months postoperatively

**Description:** 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.

**Measure:** Visual analogue scale

**Time Frame:** 12 months postoperatively

**Description:** 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.

**Measure:** Visual analogue scale

**Time Frame:** 24 months postoperatively

**Description:** 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.

**Measure:** Visual analogue scale

**Time Frame:** 36 months postoperatively

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

**Measure:** Range of motion

**Time Frame:** 3 days postoperatively

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

**Measure:** Range of motion

**Time Frame:** 2 weeks postoperatively

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

**Measure:** Range of motion

**Time Frame:** 6 weeks postoperatively

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

**Measure:** Range of motion

**Time Frame:** 3 months postoperatively

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

**Measure:** Range of motion

**Time Frame:** 6 months postoperatively

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

**Measure:** Range of motion

**Time Frame:** 12 months postoperatively

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

**Measure:** Range of motion

**Time Frame:** 24 months postoperatively

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

**Measure:** Range of motion

**Time Frame:** 36 months postoperatively

**Description:** 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.

**Measure:** knee society score

**Time Frame:** 6 weeks postoperatively

**Description:** 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.

**Measure:** knee society score

**Time Frame:** 3 months postoperatively

**Description:** 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.

**Measure:** knee society score

**Time Frame:** 6 months postoperatively

**Description:** 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.

**Measure:** knee society score

**Time Frame:** 12 months postoperatively

**Description:** 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.

**Measure:** knee society score

**Time Frame:** 24 months postoperatively

**Description:** 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.

**Measure:** knee society score

**Time Frame:** 36 months postoperatively

**Description:** 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.

**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index

**Time Frame:** 6 weeks postoperatively

**Description:** 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.

**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index

**Time Frame:** 3 months postoperatively

**Description:** 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.

**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index

**Time Frame:** 6 months postoperatively

**Description:** 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.

**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index

**Time Frame:** 12 months postoperatively

**Description:** 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.

**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index

**Time Frame:** 24 months postoperatively

**Description:** 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.

**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index

**Time Frame:** 36 months postoperatively

**Description:** At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction

**Measure:** Patient satisfaction

**Time Frame:** 6 months postoperatively

**Description:** At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction

**Measure:** Patient satisfaction

**Time Frame:** 12 months postoperatively

**Description:** At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction

**Measure:** Patient satisfaction

**Time Frame:** 24 months postoperatively

**Description:** At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction

**Measure:** Patient satisfaction

**Time Frame:** 36 months postoperatively

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

**Measure:** Length of stay

**Time Frame:** an average of 3 days postoperatively

**Description:** The total cost of a patient from admission to discharge

**Measure:** Medical expenses

**Time Frame:** an average of 3 days postoperatively

### Eligibility Module

**Eligibility Criteria:** 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.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients undergoing knee replacement in our hospital

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tianhua@bjmu.edu.cn

**Name:** Tian Hua, MD

**Phone:** 86-13511065187

**Role:** CONTACT

**Contact 2:**

**Email:** 1710301104@pku.edu.cn

**Name:** Zheng Yuhang, MD

**Phone:** 86-18811185091

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** tianhua@bjmu.edu.cn

- **Name:** Tian Hua, MD

- **Phone:** 86-18211070116

- **Role:** CONTACT

***Contact 2:***

- **Email:** 1710301104@pku.edu.cn

- **Name:** Zheng Yuhang, bachelor

- **Phone:** 86-18811185091

- **Role:** CONTACT

**Country:** China

**Facility:** Peking University Third Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100181

#### Overall Officials

**Official 1:**

**Affiliation:** Director

**Name:** Tian Hua, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** All the researchers who need it

**Description:** It will be published as an academic paper

**Info Types:**

- STUDY_PROTOCOL

- CSR

**IPD Sharing:** YES

**Time Frame:** When data collection is complete

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Knee Osteoarthritis

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Misc Info Module

- Version Holder: 2024-05-24
