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Completed

NCT Number: NCT05947734

Robot Assisted Total Hip Arthroplasties

This is a randomized controlled, multicenter study. According to the inclusion criteria, volunteers were recruited from patients undergoing total hip arthroplasty. After signing the informed consent, the subjects were assigned to the experimental group and the control group through the central randomization system. The researchers will complete the total hip arthroplasty for patients in the experimental group with the assistance of surgical robotic system. The patients in the control group do not use the surgical robotic system. The proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is the primary outcome measurement. The operation time, WOMAC score, Harris score, SF-36 and dislocation rate are the secondary outcome measurements. The incidence of complications, devices and other adverse events were recorded.

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Key information

Conditions

Hip Arthropathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100181, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of primary hip osteoarthritis(OA), fracture of femoral neck (FFN),or secondary hip osteoarthritis due to developmental dysplasia of the hip (DDH), hip avascular necrosis (AVN), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and coxa plana

Exclusion criteria

  • Severe vascular diseases of the lower extremity Neuromuscular diseases Infectious diseases Severe dysfunctions of major organs Severe neurosensory deficiencies caused by spinal diseases Unable to receive CT/MRI scans

Treatment and study plan

"VTS" surgical robotic system

Device

The"VTS" surgical robotic system can accurately match the preoperative and intraoperative image data with the patient's anatomical structure on the operating table, track and locate the surgical instruments during the operation. With the help of the robotic arm, the surgeon can make the operation procedure more accurate and safer.

Primary outcomes

  1. Acetabular location accuracy

    Time frame: Within 1 week after surgery

    Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area

Secondary outcomes

  1. Operation time

    Time frame: Immediately after surgery

    Time from skin incision to wound closure

  2. the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 6 months after surgery

    The WOMAC is a self administered questionnaire to assess joint function and quality of life for patients with osteoarthritis; it consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). The higher the total score, the worse the patient's pain, stiffness, and functional limitations. The WOMAC is validated for various languages, including Chinese

  3. Harris Hip Score (HHS)

    Time frame: 6 months after surgery

    a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion

  4. 36-Item Short Form Survey (SF-36）

    Time frame: 6 months after surgery

    The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being.

  5. dislocation rate of hip joint

    Time frame: 6 months after surgery

    the proportion of participants encountered with dislocation of hip joint after THA

  6. adverse events or complications

    Time frame: 6 months after surgery

    the rate of adverse events or complications in all the participants

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Chifeng Municipal Hospital
  • Qianfoshan Hospital

Registry information

Official study title

A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS" Surgical Robotic System

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 17, 2023
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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