Orthopaedic Trauma
Conditions
Keywords
Orthopaedic Trauma, Robotics
Brief 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.
Detailed description
1. To assess whether robotic assistance can improve surgical outcomes compared with control group. 2. To assess whether robotic assistance can improve fracture reduction compared with control group. 3. To assess whether robotic assistance can reduce complication rate compared with control group.
Interventions
DEVICERobotic 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.
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males or females aged 18 years or older * With orthopaedic trauma and fracture * Willing to participate in the study
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation Time | Baseline | Operation time will be documented from the Clinical Management System (CMS). |
| Blood Loss | Baseline | Blood loss will be documented from the Clinical Management System (CMS). |
| Length of Hospital Stay | Baseline | Length of hospital stay will be documented from the Clinical Management System (CMS). |
| Plain Radiographs | 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) | From baseline to 12-weeks post-operation | CT scan will be taken at the corresponding sites of injuries pre- and post operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life Short Form-36 (SF-36) | From baseline to 52-weeks post-operation | 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 |
| Verbal Descriptor Scale | From baseline to 52-weeks post-operation | to assess different levels of pain intensity, which has good reliability and validity in elderly patients |
| Quadriceps muscle strength | From baseline to 52-weeks post-operation | 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. |
| Times Up and Go (TUG) test | From baseline to 52-weeks post-operation | 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. |
| Handgrip strength | From baseline to 52-weeks post-operation | 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. |
| 5-time chair stand test | From baseline to 52-weeks post-operation | The time to rise from a chair 5 times is recorded. The cut-off is taken at \>=12 seconds. |
| Appendicular skeletal muscle mass (ASM) | From baseline to 52-weeks post-operation | 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). |
| 6-metre walk | From baseline to 52-weeks post-operation | Time taken to walk 6 metres without deceleration. Average result of 2 trials is recorded. Slow speed is defined as \<1.0m/s. |
| Adverse event and serious adverse event | From 2-weeks post-operation to 52-weeks post-operation | Adverse events and serious adverse events are documented from the Clinical Management System (CMS) from Hospital Authority (public computerized system for all patients). |
| Balancing ability | From baseline to 52-weeks post-operation | 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). |
Countries
China
Contacts
CONTACTRonald Man Yeung Wong
Outcome results
None listed