Orthopaedic TraumaNCT07732803
Outcomes for Robotics in Orthopaedic Trauma
A study testing Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.) in people with Orthopaedic Trauma, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in China.
Trial summary
Our project aims to integrate whether robotic assistance of reduction and fixation in orthopaedic trauma surgery can enhance accuracy and surgical outcomes. The current study aims to shorten the recovery time and reduce post-operative complications by minimally invasive surgery with robotics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthopaedic Trauma
- What is being tested?
- Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 1 Mar 2031
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females aged 18 years or older
- With orthopaedic trauma and fracture
- Willing to participate in the study
Who cannot join
- Cognitive problems e.g., severe dementia (unable to agree for consent)
- Unable to agree for consent
- Surgeons decide that surgery is not indicated for the patients
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
The Chinese University of Hong Kong
Hong Kong
Ronald Man Yeung Wong, 852 3505 1654, ronald.wong@cuhk.edu.hk
Ronald Man Yeung Wong
About this study
Our project aims to integrate whether robotic assistance of reduction and fixation in orthopaedic trauma surgery can enhance accuracy and surgical outcomes. The current study aims to shorten the recovery time and reduce post-operative complications by minimally invasive surgery with robotics.
Read the detailed description
- To assess whether robotic assistance can improve surgical outcomes compared with control group.
- To assess whether robotic assistance can improve fracture reduction compared with control group.
- To assess whether robotic assistance can reduce complication rate compared with control group.
- Conditions
- Orthopaedic Trauma
- Being tested
- Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.)
- Keywords
- Orthopaedic Trauma, Robotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.)Device
The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.) will be moved to the site of injury and held to the pins placed onto bone as the preoperative plan. The reduction process will be completed under the supervision of 3D real-time navigation. The fracture is then fixated. The robotic arm will perform precise movements during surgery for reduction to try to reduce the chance of malalignment. Moreover, these robots can allow minimally invasive surgeries.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Surgery will be performed using conventional practice without robotic assistance |
| Robot-assisted group | Experimental | The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.) will be moved to the site of injury and held to the pins placed onto bone as the preoperative plan. The reduction process will be completed under the supervision of 3D real-time navigation. The fracture is then fixated. The robotic arm will perform precise movements during surgery for reduction to try to reduce the chance of malalignment. Moreover, these robots can allow minimally invasive surgeries. Receives: Device: Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation Time
Operation time will be documented from the Clinical Management System (CMS).
Measured: Baseline
Blood Loss
Blood loss will be documented from the Clinical Management System (CMS).
Measured: Baseline
Length of Hospital Stay
Length of hospital stay will be documented from the Clinical Management System (CMS).
Measured: Baseline
Plain Radiographs
Plain radiographs will be taken at the corresponding sites of injuries post operation. The reduction quality will be assessed based on Matta criteria
Measured: From baseline to 52-weeks post-operation
Computed Tomography (CT)
CT scan will be taken at the corresponding sites of injuries pre- and post operation.
Measured: From baseline to 12-weeks post-operation
Secondary outcomes (14)
Quality of life Short Form-36 (SF-36)
is a widely accepted, well-validated functional status questionnaire to measure health-related quality of life in eight domains, including physical functioning, health perception, etc. Higher scores indicate better function
Measured: From baseline to 52-weeks post-operation
Verbal Descriptor Scale
to assess different levels of pain intensity, which has good reliability and validity in elderly patients
Measured: From baseline to 52-weeks post-operation
Quadriceps muscle strength
measured on affected limb with isometric dynamometer (Baseline, Genova, Italy). Subject will sit on a chair with both feet above ground, while raising the affected leg 45° forwards. The dynamometer is placed above the ankle and the subject will push the leg forward with maximum force. Measurements will be repeated three times and maximum value (kg) will be used for evaluation.
Measured: From baseline to 52-weeks post-operation
Times Up and Go (TUG) test
used to test basic mobility skills, which is a useful predictor of risk of falls. The subject will stand from a chair, walk 3 meters and travel back and sit back on the chair. The time (second) is recorded.
Measured: From baseline to 52-weeks post-operation
Handgrip strength
Grip strength measurement using spring-type hand dynamometer. Maximum reading (kg) of 3 trials using dominant hand in a maximum-effort isometric contraction is taken.
Measured: From baseline to 52-weeks post-operation
5-time chair stand test
The time to rise from a chair 5 times is recorded. The cut-off is taken at >=12 seconds.
Measured: From baseline to 52-weeks post-operation
Appendicular skeletal muscle mass (ASM)
Determined with Dual-energy X-ray absorptiometry (Horizon®, DXA system, Hologic, USA) or bioimpedance analysis (BIA). Total ASM by DXA is evaluated by segmented measurement of muscle mass at four limbs by operator-defined cutlines at specific anatomical landmarks. ASM is adjusted to square of height to calculate appendicular skeletal muscle mass index (ASMI) (kg/m2).
Measured: From baseline to 52-weeks post-operation
6-metre walk
Time taken to walk 6 metres without deceleration. Average result of 2 trials is recorded. Slow speed is defined as <1.0m/s.
Measured: From baseline to 52-weeks post-operation
Adverse event and serious adverse event
Adverse events and serious adverse events are documented from the Clinical Management System (CMS) from Hospital Authority (public computerized system for all patients).
Measured: From 2-weeks post-operation to 52-weeks post-operation
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different target directions without falling or moving their feet. Measured parameters of limits of stability test includes reaction time(s).
Measured: From baseline to 52-weeks post-operation
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different target directions without falling or moving their feet. Measured parameters of limits of stability test includes directional control (%).
Measured: From baseline to 52-weeks post-operation
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different target directions without falling or moving their feet. Measured parameters of limits of stability test includes movement velocity (degrees/s).
Measured: From baseline to 52-weeks post-operation
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different target directions without falling or moving their feet. Measured parameters of limits of stability test includes endpoint excursion (%).
Measured: From baseline to 52-weeks post-operation
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different target directions without falling or moving their feet. Measured parameters of limits of stability test includes maximum excursion (%).
Measured: From baseline to 52-weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Jun 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic TraumaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Man Yeung WONG, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732803
- Sponsor's protocol ID
- 2024.621
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes for Robotics in Orthopaedic Trauma
- ClinicalTrials.gov ID
- NCT07732803
- Acronym / sponsor ID
- 2024.621
- Conditions
- Orthopaedic Trauma
- Keywords
- Orthopaedic Trauma, Robotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 29 Jul 2026 (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.
Our project aims to integrate whether robotic assistance of reduction and fixation in orthopaedic trauma surgery can enhance accuracy and surgical outcomes. The current study aims to shorten the recovery time and reduce post-operative complications by minimally invasive surgery with robotics.
Detailed description
- To assess whether robotic assistance can improve surgical outcomes compared with control group.
- To assess whether robotic assistance can improve fracture reduction compared with control group.
- To assess whether robotic assistance can reduce complication rate compared with control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Surgery will be performed using conventional practice without robotic assistance |
| Robot-assisted group | Experimental | Device: Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.)The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.) will be moved to the site of injury and held to the pins placed onto bone as the preoperative plan. The reduction process will be completed under the supervision of 3D real-time navigation. The fracture is then fixated. The robotic arm will perform precise movements during surgery for reduction to try to reduce the chance of malalignment. Moreover, these robots can allow minimally invasive surgeries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females aged 18 years or older
- With orthopaedic trauma and fracture
- Willing to participate in the study
Key exclusion criteria (3 listed)
- Cognitive problems e.g., severe dementia (unable to agree for consent)
- Unable to agree for consent
- Surgeons decide that surgery is not indicated for the patients
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 Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.)The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.) will be moved to the site of injury and held to the pins placed onto bone as the preoperative plan. The reduction process will be completed under the supervision of 3D real-time navigation. The fracture is then fixated. The robotic arm will perform precise movements during surgery for reduction to try to reduce the chance of malalignment. Moreover, these robots can allow minimally invasive surgeries. | Device | Robot-assisted group |
Primary outcome
Operation Time
Time frame: Baseline
Operation time will be documented from the Clinical Management System (CMS).
Blood Loss
Time frame: Baseline
Blood loss will be documented from the Clinical Management System (CMS).
Length of Hospital Stay
Time frame: Baseline
Length of hospital stay will be documented from the Clinical Management System (CMS).
Plain Radiographs
Time frame: From baseline to 52-weeks post-operation
Plain radiographs will be taken at the corresponding sites of injuries post operation. The reduction quality will be assessed based on Matta criteria
Computed Tomography (CT)
Time frame: From baseline to 12-weeks post-operation
CT scan will be taken at the corresponding sites of injuries pre- and post operation.
14 secondary outcomes
Quality of life Short Form-36 (SF-36)
Time frame: From baseline to 52-weeks post-operation
Verbal Descriptor Scale
Time frame: From baseline to 52-weeks post-operation
Quadriceps muscle strength
Time frame: From baseline to 52-weeks post-operation
Times Up and Go (TUG) test
Time frame: From baseline to 52-weeks post-operation
Handgrip strength
Time frame: From baseline to 52-weeks post-operation
5-time chair stand test
Time frame: From baseline to 52-weeks post-operation
Appendicular skeletal muscle mass (ASM)
Time frame: From baseline to 52-weeks post-operation
6-metre walk
Time frame: From baseline to 52-weeks post-operation
Adverse event and serious adverse event
Time frame: From 2-weeks post-operation to 52-weeks post-operation
Balancing ability
Time frame: From baseline to 52-weeks post-operation
Balancing ability
Time frame: From baseline to 52-weeks post-operation
Balancing ability
Time frame: From baseline to 52-weeks post-operation
Balancing ability
Time frame: From baseline to 52-weeks post-operation
Balancing ability
Time frame: From baseline to 52-weeks post-operation
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 29 Jul 2026.
- 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.
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 Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.) in people with Orthopaedic Trauma, run by Prince of Wales Hospital, Shatin, Hong Kong 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 3 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 29 Jul 2026. 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 Ronald Man Yeung Wong (852 35051654, ronald.wong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation Time (time frame: Baseline). The study lists 5 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 29 Jul 2026.