Hip ArthropathyNCT05947734
Robot Assisted Total Hip Arthroplasties
A study testing "VTS" surgical robotic system in people with Hip Arthropathy, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- "VTS" surgical robotic system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100181
About this study
Official title: A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS" Surgical Robotic System
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
- Being tested
- "VTS" surgical robotic system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"VTS" surgical robotic systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| robotic | Experimental | Not described Receives: Device: "VTS" surgical robotic system |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular location accuracy
Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area
Measured: Within 1 week after surgery
Secondary outcomes (6)
Operation time
Time from skin incision to wound closure
Measured: Immediately after surgery
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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
Measured: 6 months after surgery
Harris Hip Score (HHS)
a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion
Measured: 6 months after surgery
36-Item Short Form Survey (SF-36）
The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being.
Measured: 6 months after surgery
dislocation rate of hip joint
the proportion of participants encountered with dislocation of hip joint after THA
Measured: 6 months after surgery
adverse events or complications
the rate of adverse events or complications in all the participants
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Apr 2021
- Primary completion1 Feb 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, Chifeng Municipal Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947734
- Sponsor's protocol ID
- VTSTHrobot
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39420701
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS" Surgical Robotic System
- ClinicalTrials.gov ID
- NCT05947734
- Acronym / sponsor ID
- VTSTHrobot
- Conditions
- Hip Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, Chifeng Municipal Hospital
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic | Experimental | Device: "VTS" surgical robotic system |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "VTS" surgical robotic systemThe"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. | Device | robotic |
Primary outcome
Acetabular location accuracy
Time frame: Within 1 week after surgery
Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area
6 secondary outcomes
Operation time
Time frame: Immediately after surgery
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 months after surgery
Harris Hip Score (HHS)
Time frame: 6 months after surgery
36-Item Short Form Survey (SF-36）
Time frame: 6 months after surgery
dislocation rate of hip joint
Time frame: 6 months after surgery
adverse events or complications
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 39420701Geng 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.
- Individual participant dataSharing planned: No
Related trials for Hip Arthropathy
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Hip OA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "VTS" surgical robotic system in people with Hip Arthropathy, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetabular location accuracy (time frame: Within 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05947734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.