Robot Assisted Total Hip Arthroplasties

NCT05947734 | Completed

• 1 other identifier: VTSTHrobot
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Arthropathy

Outcome Measures

Primary Outcomes (1)

• Acetabular location accuracy

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

  Within 1 week after surgery

Secondary Outcomes (6)

• Operation time

  Immediately after surgery

• the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  6 months after surgery

• Harris Hip Score (HHS)

  6 months after surgery

• 36-Item Short Form Survey (SF-36）

  6 months after surgery

• dislocation rate of hip joint

  6 months after surgery

Study Arms (2)

robotic

EXPERIMENTAL

Device: "VTS" surgical robotic system

Control

NO INTERVENTION

Interventions

"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.

robotic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Qianfoshan Hospital: collaborator
• Chifeng Municipal Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100181, China

Location

Related Publications (1)

• Geng X, Dong Z, Li Y, Zhao M, Liu Y, Li Z, Cai H, Zhang M, Yan X, Sun Z, Lv X, Guo F, Li F, Tian H. Precise Acetabular Prosthesis Positioning Using a Novel Robot-Assisted Total Hip Arthroplasty System: A Multicenter, Randomized Controlled Trial. Orthop Surg. 2025 Jan;17(1):141-150. doi: 10.1111/os.14277. Epub 2024 Oct 17.

  PMID: 39420701 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 17, 2023
• Study Start: April 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)