Outcomes for Robotics in Orthopaedic Trauma
ConditionOrthopaedic Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrince of Wales Hospital, Shatin, Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females aged 18 years or older
With orthopaedic trauma and fracture
Willing to participate in the study
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.)
DeviceThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Robot-assisted groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Operation Time
Operation time will be documented from the Clinical Management System (CMS).
Time frame
Baseline2
Blood Loss
Blood loss will be documented from the Clinical Management System (CMS).
Time frame
Baseline3
Length of Hospital Stay
Length of hospital stay will be documented from the Clinical Management System (CMS).
Time frame
Baseline4
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-operationSecondary outcomes
1
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-operation2
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-operation3
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-operation4
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-operationSponsors and contacts
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Source ClinicalTrials.gov