An interventional study of Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.) in Orthopaedic Trauma, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Not applicable, Interventional, and Supportive care
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.
Prince of Wales Hospital, Shatin, Hong Kong is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Surgery will be performed using conventional practice without robotic assistance
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: 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.
Operation Time
Operation time will be documented from the Clinical Management System (CMS).
Time frame: Baseline
Blood Loss
Blood loss will be documented from the Clinical Management System (CMS).
Time frame: Baseline
Length of Hospital Stay
Length of hospital stay will be documented from the Clinical Management System (CMS).
Time frame: 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
Time frame: 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.
Time frame: From baseline to 12-weeks post-operation
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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 (%).
Time frame: From baseline to 52-weeks post-operation
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Prince of Wales Hospital, Shatin, Hong Kong