Cruciate Ligament RuptureNCT04980183
A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments
A study testing Arthroscopic surgical robot and Conventional arthroscopic cruciate ligament reconstruction in people with Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
Trial summary
30 patients with the first rupture of the cruciate ligament were divided into two groups as 1:1. Experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction. Control group will be treated with conventional reconstruction. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Cruciate Ligament Rupture
- What is being tested?
- Arthroscopic surgical robot and Conventional arthroscopic cruciate ligament reconstruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 18-45 years old, with closed epiphyses;
- For the first time, the knee joint is simply ruptured with a cruciate ligament and requires surgical reconstruction; it can be combined with meniscus injury, and the Outerbridge injury score is ≤ II;
- There is no history of trauma or fracture of the ipsilateral knee joint;
- The medial collateral ligament or the lateral collateral ligament is not damaged or only slightly damaged (no more than degree I).
Who cannot join
- BMI is less than 18.5 or greater than 35 kg/m2;
- Patients with moderate or severe knee degeneration;
- Those with limited flexion angle (<120 degrees);
- Cartilage defect area is greater than 2 cm2 or Outerbridge damage score> Grade II.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
Beijing, Beijing Municipality, 100191
About this study
30 patients with the first rupture of the cruciate ligament were divided into two groups as 1:1. Experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction. Control group will be treated with conventional reconstruction. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.
Read the detailed description
In this study, 30 patients with the first rupture of the cruciate ligament were recruited as the research objects, and the ratio of the experimental group and the control group was 1:1. Patients in the experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction, and patients in the control group will be treated with conventional reconstruction. All subjects will undergo CT evaluation and clinical function evaluation. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.
- Conditions
- Cruciate Ligament Rupture
- Being tested
- Arthroscopic surgical robot, Conventional arthroscopic cruciate ligament reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic surgical robotDevice
The surgeon performs cruciate ligament bone canal positioning and ligament reconstruction with the assistance of an arthroscopic surgical robot
Conventional arthroscopic cruciate ligament reconstructionDevice
The surgeon performs conventional arthroscopic cruciate ligament reconstruction surgery without other auxiliary equipment
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic surgical robot assisted navigation and positioning for cruciate ligament reconstruction | Experimental | Patient undergoes cruciate ligament reconstruction with robot-assisted navigation and positioning under arthroscopic surgery Receives: Device: Arthroscopic surgical robot |
| Conventional arthroscopic cruciate ligament reconstruction | Active comparator | The patient undergoes conventional arthroscopic cruciate ligament reconstruction Receives: Device: Conventional arthroscopic cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D-CT compares the position of the tibial canal made by the robot-assisted positioning and the traditional positioning method
Evaluate the position of the reconstructed tibia canal through 3D-CT using Taukada's method, t / T × 100% was used to evaluate the anteroposterior radial orientation of the tibial tract. Use l / L × 100% to evaluate the orientation of the inner and outer diameters of the tibial tract.
Measured: Knee CT examinations were performed on patients one week after surgery
3D-CT compares the position of the femoral canal made by the robot-assisted positioning and the traditional positioning method
Evaluate the position of the reconstructed femoral canal through 3D-CT according to Bernard and Hertel (BH) quadrant method, l / L × 100% and h / H × 100% are used to evaluate the femoral bone canal positioning.
Measured: Knee CT examinations were performed on patients one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cruciate Ligament RuptureStudies 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
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingfang Ao, Prof., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980183
- Sponsor's protocol ID
- M2021156
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments
- ClinicalTrials.gov ID
- NCT04980183
- Acronym / sponsor ID
- M2021156
- Conditions
- Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 28 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.
30 patients with the first rupture of the cruciate ligament were divided into two groups as 1:1. Experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction. Control group will be treated with conventional reconstruction. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.
Detailed description
In this study, 30 patients with the first rupture of the cruciate ligament were recruited as the research objects, and the ratio of the experimental group and the control group was 1:1. Patients in the experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction, and patients in the control group will be treated with conventional reconstruction. All subjects will undergo CT evaluation and clinical function evaluation. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic surgical robot assisted navigation and positioning for cruciate ligament reconstruction | Experimental | Device: Arthroscopic surgical robotPatient undergoes cruciate ligament reconstruction with robot-assisted navigation and positioning under arthroscopic surgery |
| Conventional arthroscopic cruciate ligament reconstruction | Active comparator | Device: Conventional arthroscopic cruciate ligament reconstructionThe patient undergoes conventional arthroscopic cruciate ligament reconstruction |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 18-45 years old, with closed epiphyses;
- For the first time, the knee joint is simply ruptured with a cruciate ligament and requires surgical reconstruction; it can be combined with meniscus injury, and the Outerbridge injury score is ≤ II;
- There is no history of trauma or fracture of the ipsilateral knee joint;
- The medial collateral ligament or the lateral collateral ligament is not damaged or only slightly damaged (no more than degree I).
Key exclusion criteria (4 listed)
- BMI is less than 18.5 or greater than 35 kg/m2;
- Patients with moderate or severe knee degeneration;
- Those with limited flexion angle (<120 degrees);
- Cartilage defect area is greater than 2 cm2 or Outerbridge damage score> Grade II.
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 |
|---|---|---|
| Arthroscopic surgical robotThe surgeon performs cruciate ligament bone canal positioning and ligament reconstruction with the assistance of an arthroscopic surgical robot | Device | Arthroscopic surgical robot assisted navigation and positioning for cruciate ligament reconstruction |
| Conventional arthroscopic cruciate ligament reconstructionThe surgeon performs conventional arthroscopic cruciate ligament reconstruction surgery without other auxiliary equipment | Device | Conventional arthroscopic cruciate ligament reconstruction |
Primary outcome
3D-CT compares the position of the tibial canal made by the robot-assisted positioning and the traditional positioning method
Time frame: Knee CT examinations were performed on patients one week after surgery
Evaluate the position of the reconstructed tibia canal through 3D-CT using Taukada's method, t / T × 100% was used to evaluate the anteroposterior radial orientation of the tibial tract. Use l / L × 100% to evaluate the orientation of the inner and outer diameters of the tibial tract.
3D-CT compares the position of the femoral canal made by the robot-assisted positioning and the traditional positioning method
Time frame: Knee CT examinations were performed on patients one week after surgery
Evaluate the position of the reconstructed femoral canal through 3D-CT according to Bernard and Hertel (BH) quadrant method, l / L × 100% and h / H × 100% are used to evaluate the femoral bone canal positioning.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
Yingfang Ao, Prof. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic surgical robot and Conventional arthroscopic cruciate ligament reconstruction in people with Cruciate Ligament Rupture, 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 4 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 28 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Zhang, Ph.D. (18811332558, caochenxi116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D-CT compares the position of the tibial canal made by the robot-assisted positioning and the traditional positioning method (time frame: Knee CT examinations were performed on patients one week after surgery). The study lists 2 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 28 Jul 2021.