Total Knee AnthroplastyRA-TKANCT06638047
Early Clinical and Radiological Outcomes of a Novel Robotic TKA System
A study testing robotic-assisted TKA and CI-TKA in people with Total Knee Anthroplasty and Robotic Surgery, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Anthroplasty, Robotic Surgery
- What is being tested?
- robotic-assisted TKA and CI-TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2022to 13 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-85 years (including 18 and 85), regardless of gender;
- Patients scheduled for unilateral primary total knee arthroplasty based on the clinical judgment of the study physician;
- The subject or their guardian has been informed of the study, agrees to all terms of the trial, signs an informed consent form approved by the ethics committee, and agrees to participate in the trial.
Who cannot join
- The side scheduled for surgery has significant hip joint disease, such as substantial bone defects or severe limitations in joint mobility;
- Patients with active infections around the knee joint or systemic infections;
- Discontinuity or severe functional loss of the knee extensor mechanism, painless knee joint fusion, Charcot joint, poor surgical tolerance, or other conditions that may adversely affect surgical prognosis;
- Patients with contraindications for traditional TKA surgery;
- Pregnant or breastfeeding women;
- Patients known to have excessive alcohol consumption or substance abuse; Body mass index (BMI) > 35 kg/m²;
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- Patients who have participated in other clinical trials within one month prior to signing the informed consent form;
- Patients with mental or intellectual disabilities that may affect clinical outcome evaluations;
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.
144 patients undergoing primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes will include coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).
- Conditions
- Total Knee Anthroplasty, Robotic Surgery
- Being tested
- robotic-assisted TKA, CI-TKA
- Keywords
- total knee arthroplasty, robot, radiological, clinical outcome, postoperative alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic-assisted TKAProcedure or surgery
Robotic-assisted TKA means that TKA surgery is operated with the guidance of robotic system.
CI-TKAProcedure or surgery
TKA operated with conventional instruments
| Study group | Role | What they receive |
|---|---|---|
| RA TKA | Experimental | Robotic-assisted TKA Receives: Procedure: robotic-assisted TKA |
| CI TKA | Active comparator | TKA with conventional instruments Receives: Procedure: CI-TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
HKA outliers
the proportion of patients with a deviation of ≤ 3° between the mechanical axis (hip-knee-ankle angle, or HKA angle) measured from a full-length, frontal-view lower limb X-ray
Measured: 12 weeks post-surgery
Secondary outcomes (14)
FFC angle
frontal femoral component (FFC) angle
Measured: 12 weeks post-surgery
outliers of FFC angle
outliers of frontal femoral component (FFC) angle (>3 degree)
Measured: 12 weeks post-surgery
FTC angle
frontal tibia component (FTC) angle
Measured: 12 weeks post-surgery
outliers of FTC angle
outliers of frontal tibia component (FTC) angle (>3 degree)
Measured: 12 weeks post-surgery
LFC angle
lateral femoral component (LFC) angle
Measured: 12 weeks post-surgery
outliers of LFC angle
outliers of lateral femoral component (LFC) angle (>3 degree)
Measured: 12 weeks post-surgery
LTC angle
lateral tibia component (LTC) angle
Measured: 12 weeks post-surgery
outliers of LTC angle
outliers of lateral tibia component (LTC) angle (>3 degree)
Measured: 12 weeks post-surgery
Surgical duration
In this study, surgical duration is defined as the time from the first incision to the completion of skin closure
Measured: During operation
Blood loss
Postoperative blood loss is calculated using the Gross formula in this study. The Gross equation was used to calculate the total blood loss (mL) as preoperative blood volume×(preoperative HCT level-postoperative HCT level).
Measured: 3 days after surgery
ROM
ROM refers to the maximum passive range of knee motion
Measured: 12 weeks post-surgery
Knee Society Score (KSS)
The KSS, developed by the American Knee Society, evaluates objective knee indicators, symptoms, patient satisfaction, patient expectations, and functional activities. A total score above 85 is considered excellent, 70-84 is good, 60-69 is fair, and below 60 is poor.
Measured: screening and 12 weeks post-surgery.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC measures knee function in terms of pain, stiffness, and physical function across 25 items. Pain is assessed with five items, stiffness with two items, and physical function with 18 items. Each item is scored from 0 to 4, with higher scores indicating more severe symptoms.
Measured: screening and 12 weeks post-surgery.
Incidence of adverse events and serious adverse events
Throughout the study, any adverse events that occurred were recorded, and the corresponding incidence was calculated.
Similarly, any serious adverse events that occurred during the study were recorded, and the corresponding incidence was calculated.
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start8 Sep 2022
- Primary completion2 Feb 2023
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee AnthroplastyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tian Hua, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638047
- Sponsor's protocol ID
- JUST-RA-TKA
- Acronym
- RA-TKA
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical and Radiological Outcomes of a Novel Robotic TKA System
- ClinicalTrials.gov ID
- NCT06638047
- Acronym / sponsor ID
- RA-TKA / JUST-RA-TKA
- Conditions
- Total Knee Anthroplasty, Robotic Surgery
- Keywords
- total knee arthroplasty, robot, radiological, clinical outcome, postoperative alignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 15 Oct 2024 (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.
This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.
144 patients undergoing primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes will include coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA TKA | Experimental | Procedure: robotic-assisted TKARobotic-assisted TKA |
| CI TKA | Active comparator | Procedure: CI-TKATKA with conventional instruments |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-85 years (including 18 and 85), regardless of gender;
- Patients scheduled for unilateral primary total knee arthroplasty based on the clinical judgment of the study physician;
- The subject or their guardian has been informed of the study, agrees to all terms of the trial, signs an informed consent form approved by the ethics committee, and agrees to participate in the trial.
Key exclusion criteria (9 listed)
- The side scheduled for surgery has significant hip joint disease, such as substantial bone defects or severe limitations in joint mobility;
- Patients with active infections around the knee joint or systemic infections;
- Discontinuity or severe functional loss of the knee extensor mechanism, painless knee joint fusion, Charcot joint, poor surgical tolerance, or other conditions that may adversely affect surgical prognosis;
- Patients with contraindications for traditional TKA surgery;
- Pregnant or breastfeeding women;
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 |
|---|---|---|
| robotic-assisted TKARobotic-assisted TKA means that TKA surgery is operated with the guidance of robotic system. | Procedure or surgery | RA TKA |
| CI-TKATKA operated with conventional instruments | Procedure or surgery | CI TKA |
Primary outcome
HKA outliers
Time frame: 12 weeks post-surgery
the proportion of patients with a deviation of ≤ 3° between the mechanical axis (hip-knee-ankle angle, or HKA angle) measured from a full-length, frontal-view lower limb X-ray
14 secondary outcomes
FFC angle
Time frame: 12 weeks post-surgery
outliers of FFC angle
Time frame: 12 weeks post-surgery
FTC angle
Time frame: 12 weeks post-surgery
outliers of FTC angle
Time frame: 12 weeks post-surgery
LFC angle
Time frame: 12 weeks post-surgery
outliers of LFC angle
Time frame: 12 weeks post-surgery
LTC angle
Time frame: 12 weeks post-surgery
outliers of LTC angle
Time frame: 12 weeks post-surgery
Surgical duration
Time frame: During operation
Blood loss
Time frame: 3 days after surgery
ROM
Time frame: 12 weeks post-surgery
Knee Society Score (KSS)
Time frame: screening and 12 weeks post-surgery.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: screening and 12 weeks post-surgery.
Incidence of adverse events and serious adverse events
Time frame: Through study completion, an average of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic-assisted TKA and CI-TKA in people with Total Knee Anthroplasty and Robotic Surgery, run by Peking University Third Hospital 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 9 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: finished, as of the sponsor's last update on 15 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HKA outliers (time frame: 12 weeks post-surgery). 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 15 Oct 2024.