NCT07732803

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Mar 2031

Study Start

First participant enrolled

June 15, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

3.7 years

First QC Date

July 3, 2026

Last Update Submit

July 26, 2026

Conditions

Orthopaedic Trauma

Keywords

Orthopaedic TraumaRobotics

Outcome Measures

Primary Outcomes (5)

  • Operation Time

    Operation time will be documented from the Clinical Management System (CMS).

    Baseline

  • Blood Loss

    Blood loss will be documented from the Clinical Management System (CMS).

    Baseline

  • Length of Hospital Stay

    Length of hospital stay will be documented from the Clinical Management System (CMS).

    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

    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.

    From baseline to 12-weeks post-operation

Secondary Outcomes (14)

  • Quality of life Short Form-36 (SF-36)

    From baseline to 52-weeks post-operation

  • Verbal Descriptor Scale

    From baseline to 52-weeks post-operation

  • Quadriceps muscle strength

    From baseline to 52-weeks post-operation

  • Times Up and Go (TUG) test

    From baseline to 52-weeks post-operation

  • Handgrip strength

    From baseline to 52-weeks post-operation

  • +9 more secondary outcomes

Study Arms (2)

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.

Device: Robotic Assistance: The robotic system (R-Universal® Intelligent Robotic Surgical Systems, Beijing Rossum Robot Technology Co., Ltd.)

Interventions

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.

Robot-assisted group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females aged 18 years or older
  • With orthopaedic trauma and fracture
  • Willing to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, China

RECRUITING

Central Study Contacts

Ronald Man Yeung Wong

CONTACT

852 35051654ronald.wong@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 29, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

February 28, 2030

Study Completion (Estimated)

March 1, 2031

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)