Outcomes for Robotics in Orthopaedic Trauma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.).
- Who it may be relevant to
- Registry conditions: Orthopaedic Trauma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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 in
Primary outcome measures
- Operation Time [Time frame: Baseline]
- Blood Loss [Time frame: Baseline]
- Length of Hospital Stay [Time frame: Baseline]
- Plain Radiographs [Time frame: From baseline to 52-weeks post-operation]
- Computed Tomography (CT) [Time frame: From baseline to 12-weeks post-operation]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- The Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT07732803 · 2024.621