Osteoarthritis, KneeNCT04953988
Technology and System for Minimally Invasive TKA Surgery Robot
A study testing Robotic TKA and Manual operation in people with Osteoarthritis, Knee, run by Peking University Third Hospital.
Trial summary
Developed a robot for minimally invasive TKA surgery and prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Robotic TKA and Manual operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Aug 2023
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No surgery on the knee joint.
- Age>55
Who cannot join
- Knee surgery history.
- Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability.
- Severe flexion contracture deformity.
- Revision and replacement surgery for knee joints.
About this study
Developed a robot for minimally invasive TKA surgery and prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.
Read the detailed description
- For the current minimally invasive total knee arthroplasty, due to the limitation of the surgical field of view and the scope of operation, and the error of the intraoperative osteotomy saw, it can cause intraoperative damage to ligaments, nerves and blood vessels, postoperative lower limb force lines and prosthesis position Poor, abnormal movement and force of the patellofemoral joint and tibiofemoral joint after surgery can easily lead to clinical symptoms such as rapid wear of the prosthesis, short service life, postoperative knee pain, and even possible problems with surgical failure and revision. Developed a robot for minimally invasive total knee replacement surgery. Minimally invasive total knee arthroplasty is performed by surgical robot and manual operation. According to intraoperative and postoperative imaging observations, the position of the prosthesis, and the evaluation of soft tissue balance during and after the operation, the two methods are compared with the surgical robot and manual operation. Kind of surgery.
- To prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Robotic TKA, Manual operation
- Keywords
- KOA, TKA, robotic surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic TKAProcedure or surgery
Robotic TKA
Manual operationProcedure or surgery
Manual operation
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery group | Experimental | Not described Receives: Procedure: Robotic TKA |
| Manual operation group | Active comparator | Not described Receives: Procedure: Manual operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full-length radiography of both lower limbs
Measurement of lower limb force line and prosthesis position through full-length radiography of both lower limbs
Measured: Before and two days after the operation
Conventional anteroposterior radiograph of Both Lower Extremities
Measurement of lower limb force line and prosthesis position through conventional anteroposterior radiograph of Both Lower Extremities
Measured: Before and two days after the operation
computed tomography
Measurement of lower limb force line and prosthesis position through computed tomography
Measured: Before and two days after the operation
Magnetic Resonance Imaging
Measurement of lower limb force line and prosthesis position through Magnetic Resonance Imaging
Measured: Before and two days after the operation
Range of motion
Knee joint range of motion. Normal flexion 150°, extension 0°
Measured: Before and two days after the operation
Operation time
The time from the start of the skin incision to the completion of the skin suture
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953988
- Sponsor's protocol ID
- M2021188
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology and System for Minimally Invasive TKA Surgery Robot
- ClinicalTrials.gov ID
- NCT04953988
- Acronym / sponsor ID
- M2021188
- Conditions
- Osteoarthritis, Knee
- Keywords
- KOA, TKA, robotic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 8 Jul 2021 (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.
Developed a robot for minimally invasive TKA surgery and prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.
Detailed description
- For the current minimally invasive total knee arthroplasty, due to the limitation of the surgical field of view and the scope of operation, and the error of the intraoperative osteotomy saw, it can cause intraoperative damage to ligaments, nerves and blood vessels, postoperative lower limb force lines and prosthesis position Poor, abnormal movement and force of the patellofemoral joint and tibiofemoral joint after surgery can easily lead to clinical symptoms such as rapid wear of the prosthesis, short service life, postoperative knee pain, and even possible problems with surgical failure and revision. Developed a robot for minimally invasive total knee replacement surgery. Minimally invasive total knee arthroplasty is performed by surgical robot and manual operation. According to intraoperative and postoperative imaging observations, the position of the prosthesis, and the evaluation of soft tissue balance during and after the operation, the two methods are compared with the surgical robot and manual operation. Kind of surgery.
- To prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery group | Experimental | Procedure: Robotic TKA |
| Manual operation group | Active comparator | Procedure: Manual operation |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No surgery on the knee joint.
- Age>55
Key exclusion criteria (4 listed)
- Knee surgery history.
- Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability.
- Severe flexion contracture deformity.
- Revision and replacement surgery for knee joints.
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 TKARobotic TKA | Procedure or surgery | Robotic surgery group |
| Manual operationManual operation | Procedure or surgery | Manual operation group |
Primary outcome
Full-length radiography of both lower limbs
Time frame: Before and two days after the operation
Measurement of lower limb force line and prosthesis position through full-length radiography of both lower limbs
Conventional anteroposterior radiograph of Both Lower Extremities
Time frame: Before and two days after the operation
Measurement of lower limb force line and prosthesis position through conventional anteroposterior radiograph of Both Lower Extremities
computed tomography
Time frame: Before and two days after the operation
Measurement of lower limb force line and prosthesis position through computed tomography
Magnetic Resonance Imaging
Time frame: Before and two days after the operation
Measurement of lower limb force line and prosthesis position through Magnetic Resonance Imaging
Range of motion
Time frame: Before and two days after the operation
Knee joint range of motion. Normal flexion 150°, extension 0°
Operation time
Time frame: During the operation
The time from the start of the skin incision to the completion of the skin suture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic TKA and Manual operation in people with Osteoarthritis, Knee, run by Peking University Third Hospital.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Full-length radiography of both lower limbs (time frame: Before and two days after the operation). The study lists 6 primary outcomes in all. 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 8 Jul 2021.