Knee OsteoarthritisNCT06010979
Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
An observational study of Knee Osteoarthritis, run by Tian Hua at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- conventional intrumentation assisted knee arthroplasty, computer navigation assisted knee arthroplasty and robotic system assisted knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing knee replacement in our hospital
Who may be able to join
- a. primary knee osteoarthritis;
- b. Unilateral primary knee replacement;
- c. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100181
Tian Hua, MD, 86-18211070116, tianhua@bjmu.edu.cn
Zheng Yuhang, bachelor, 86-18811185091, 1710301104@pku.edu.cn
About this study
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.
Read the 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
- Knee Osteoarthritis
- Being tested
- conventional intrumentation assisted knee arthroplasty, computer navigation assisted knee arthroplasty, robotic system assisted knee arthroplasty, patient-spercific assisted knee arthroplasty
- Keywords
- total knee arthroplasty, knee osteoarthritis, computer navigation, robotic system, patient-spercific instrumentation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional intrumentation assisted knee arthroplastyProcedure or surgery
conventional intrumentation assisted knee arthroplasty
computer navigation assisted knee arthroplastyProcedure or surgery
computer navigation assisted knee arthroplasty
robotic system assisted knee arthroplastyProcedure or surgery
robotic system assisted knee arthroplasty
patient-spercific assisted knee arthroplastyProcedure or surgery
patient-spercific assisted knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Conventional instrument-assisted knee arthroplasty Receives: Procedure: conventional intrumentation assisted knee arthroplasty | |
| CAS group | computer navigation assisted knee arthroplasty Receives: Procedure: computer navigation assisted knee arthroplasty | |
| RAS group | robotic system assisted knee arthroplasty Receives: Procedure: robotic system assisted knee arthroplasty | |
| PSI group | patient-spercific instrumentation assisted knee arthroplasty Receives: Procedure: patient-spercific assisted knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 3
Secondary outcomes (41)
operation time
The surgical time is defined as the time from incision to the completion of the skin suture, accurate to minutes
Measured: 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
Measured: immediately after the surgery
Intraoperative complications
Various complications occurred during the operation were recorded
Measured: 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;
Measured: 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.
Measured: At discharge
Postoperative complication
The postoperative complications such as wound nonunion, wound infection, hematomas and anemia were recorded.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Measured: 3 days postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Measured: 2 weeks postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Measured: 6 weeks postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Measured: 3 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Measured: 6 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Measured: 12 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Measured: 24 months postoperatively
Range of motion
The Range of motion of the knee on the operative side of the patient was measured
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 36 months postoperatively
Length of stay
The number of days a patient stays in hospital from admission to discharge
Measured: an average of 3 days postoperatively
Medical expenses
The total cost of a patient from admission to discharge
Measured: an average of 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 12,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tian Hua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tian Hua, Peking University Third Hospital
- Investigators
- Tian Hua, MD, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010979
- Sponsor's protocol ID
- TKAcohort
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be published as an academic paper
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
- ClinicalTrials.gov ID
- NCT06010979
- Acronym / sponsor ID
- TKAcohort
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, knee osteoarthritis, computer navigation, robotic system, patient-spercific instrumentation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Tian HuaUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| conventional group | – | Procedure: conventional intrumentation assisted knee arthroplastyConventional instrument-assisted knee arthroplasty |
| CAS group | – | Procedure: computer navigation assisted knee arthroplastycomputer navigation assisted knee arthroplasty |
| RAS group | – | Procedure: robotic system assisted knee arthroplastyrobotic system assisted knee arthroplasty |
| PSI group | – | Procedure: patient-spercific assisted knee arthroplastypatient-spercific instrumentation assisted knee arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing knee replacement in our hospital
Key inclusion criteria (3 listed)
- a. primary knee osteoarthritis;
- b. Unilateral primary knee replacement;
- c. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional intrumentation assisted knee arthroplastyconventional intrumentation assisted knee arthroplasty | Procedure or surgery | conventional group |
| computer navigation assisted knee arthroplastycomputer navigation assisted knee arthroplasty | Procedure or surgery | CAS group |
| robotic system assisted knee arthroplastyrobotic system assisted knee arthroplasty | Procedure or surgery | RAS group |
| patient-spercific assisted knee arthroplastypatient-spercific assisted knee arthroplasty | Procedure or surgery | PSI group |
Primary outcome
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.
41 secondary outcomes
operation time
Time frame: immediately after the surgery
Intraoperative blood loss
Time frame: immediately after the surgery
Intraoperative complications
Time frame: immediately after the surgery
Total postoperative blood loss
Time frame: Postoperative day 3
Blood transfusion rate
Time frame: At discharge
Postoperative complication
Time frame: 3 years postoperatively
Rotation Angle of femur prosthesis
Time frame: Postoperative day 3
Visual analogue scale
Time frame: Postoperative day 3
Visual analogue scale
Time frame: 2 weeks postoperatively
Visual analogue scale
Time frame: 6 weeks postoperatively
Visual analogue scale
Time frame: 3 months postoperatively
Visual analogue scale
Time frame: 6 months postoperatively
Visual analogue scale
Time frame: 12 months postoperatively
Visual analogue scale
Time frame: 24 months postoperatively
Visual analogue scale
Time frame: 36 months postoperatively
Range of motion
Time frame: 3 days postoperatively
Range of motion
Time frame: 2 weeks postoperatively
Range of motion
Time frame: 6 weeks postoperatively
Range of motion
Time frame: 3 months postoperatively
Range of motion
Time frame: 6 months postoperatively
Range of motion
Time frame: 12 months postoperatively
Range of motion
Time frame: 24 months postoperatively
Range of motion
Time frame: 36 months postoperatively
knee society score
Time frame: 6 weeks postoperatively
knee society score
Time frame: 3 months postoperatively
knee society score
Time frame: 6 months postoperatively
knee society score
Time frame: 12 months postoperatively
knee society score
Time frame: 24 months postoperatively
knee society score
Time frame: 36 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 6 weeks postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 3 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 6 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 12 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 24 months postoperatively
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 36 months postoperatively
Patient satisfaction
Time frame: 6 months postoperatively
Patient satisfaction
Time frame: 12 months postoperatively
Patient satisfaction
Time frame: 24 months postoperatively
Patient satisfaction
Time frame: 36 months postoperatively
Length of stay
Time frame: an average of 3 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Yes. It will be published as an academic paper
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tian Hua, MD study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Tian Hua at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian Hua, MD (86-13511065187, tianhua@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical axis (time frame: Postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.