Legg-Calvé-Perthes DiseaseNCT07122323
Robotic Arm-assisted THA Vs. Conventional THA in Legg-Calvé-Perthes Disease
A study testing robotic arm-assisted total hip replacement and conventional total hip replacement in people with Legg-Calvé-Perthes Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Flat hip, also called Legg-Calvé-Perthes disease, is clinically characterized by flattened femoral head, shortened femoral neck, and a center of rotation of the femoral head lower than the apex of the greater trochanter. Joint replacement is difficult, with high intraoperative and postoperative complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Legg-Calvé-Perthes Disease
- What is being tested?
- robotic arm-assisted total hip replacement and conventional total hip replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2025to 28 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- patients with Legg-Calvé-Perthes disease and accept total hip replacement in our center
Who cannot join
- infection, cannot complete follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Comparison of Robotic Arm-assisted THA and Conventional Manual THA in Patients With Legg-Calvé-Perthes Disease: a Prospective Cohort Study
Flat hip, also called Legg-Calvé-Perthes disease, is clinically characterized by flattened femoral head, shortened femoral neck, and a center of rotation of the femoral head lower than the apex of the greater trochanter. Joint replacement is difficult, with high intraoperative and postoperative complications. Especially, issues such as unequal limb length, postoperative dislocation, postoperative neurological damage, and prosthesis impact have always plagued clinical practice.
The robotic arm-assisted joint replacement technology has been developed and clinically applied for over 10 years, but it was not until the past 3 years that it began to be widely implemented worldwide. Existing research data indicates that robotic arm-assisted joint replacement technology can significantly improve the placement of prostheses and lower limb force lines in patients, and improve their short-term clinical prognosis. However, its application in complex hips, such as flat hip, is limited. More relevant literature is needed to further enrich people's understanding of this technology. In theory, robot assisted technology can solve many challenges faced in flat hip replacement.
- Conditions
- Legg-Calvé-Perthes Disease
- Being tested
- robotic arm-assisted total hip replacement, conventional total hip replacement
- Keywords
- MAKO, Legg-Calvé-Perthes disease, flat hip
- Medical subject headings
- Legg-Calve-Perthes Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic arm-assisted total hip replacementProcedure or surgery
using robotic total hip replacement in patients with Legg-Calvé-Perthes disease
conventional total hip replacementProcedure or surgery
applying conventional total hip replacement in patients with Legg-Calvé-Perthes disease
| Study group | Role | What they receive |
|---|---|---|
| conventional total hip replacement | Active comparator | applying conventional total hip replacement in patients with Legg-Calvé-Perthes disease Receives: Procedure: conventional total hip replacement |
| robotic arm-assisted total hip replacement | Experimental | applying robotic arm-assisted total hip replacement in patients with Legg-Calvé-Perthes disease Receives: Procedure: robotic arm-assisted total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
inclination angle
The inclination angle in total hip replacement (THR), also called the abduction angle , refers to the angle at which the acetabular cup component is tilted relative to the horizontal plane when viewed on an anteroposterior (AP) pelvic X-ray.
Measured: 2 days after surgery
anteversion angle
The anteversion angle in total hip replacement (THR) refers to the forward tilt (rotation) of the acetabular cup component around its vertical axis. It determines whether the cup's opening faces more forward or backward relative to the pelvis.
Measured: 2 days after surgery
Hospital for Special Surgery Score score (HSS score)
The maximum values is 100, and the minimum value is 0. Higher scores means a better outcome.
Measured: before the surgery, 1 week after surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery
Secondary outcomes (3)
operation duration
The operation duration (also called operative time or surgical time ) refers to the total time taken to complete a surgical procedure.
Measured: during the operation
blood loss
The amount of blood loss during the surgery.
Measured: during the operation
Visual Analogue Scale score (VAS score)
The maximum value is 10, and the minimum value is 0. Lower score means a better outcome.
Measured: before the surgery, 1 week after surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start28 Jul 2025
- Primary completion28 Jul 2027 (estimated)
- Study completion28 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legg-Calvé-Perthes DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Zhao, MD, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122323
- Sponsor's protocol ID
- 2025-1100
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Robotic Arm-assisted THA and Conventional Manual THA in Patients With Legg-Calvé-Perthes Disease: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07122323
- Acronym / sponsor ID
- 2025-1100
- Conditions
- Legg-Calvé-Perthes Disease
- Keywords
- MAKO, Legg-Calvé-Perthes disease, flat hip
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 28 Jul 2027 (estimated)
- Study completion
- 28 Jul 2027 (estimated)
- First posted
- 14 Aug 2025 (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.
Flat hip, also called Legg-Calvé-Perthes disease, is clinically characterized by flattened femoral head, shortened femoral neck, and a center of rotation of the femoral head lower than the apex of the greater trochanter. Joint replacement is difficult, with high intraoperative and postoperative complications. Especially, issues such as unequal limb length, postoperative dislocation, postoperative neurological damage, and prosthesis impact have always plagued clinical practice.
The robotic arm-assisted joint replacement technology has been developed and clinically applied for over 10 years, but it was not until the past 3 years that it began to be widely implemented worldwide. Existing research data indicates that robotic arm-assisted joint replacement technology can significantly improve the placement of prostheses and lower limb force lines in patients, and improve their short-term clinical prognosis. However, its application in complex hips, such as flat hip, is limited. More relevant literature is needed to further enrich people's understanding of this technology. In theory, robot assisted technology can solve many challenges faced in flat hip replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional total hip replacement | Active comparator | Procedure: conventional total hip replacementapplying conventional total hip replacement in patients with Legg-Calvé-Perthes disease |
| robotic arm-assisted total hip replacement | Experimental | Procedure: robotic arm-assisted total hip replacementapplying robotic arm-assisted total hip replacement in patients with Legg-Calvé-Perthes disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with Legg-Calvé-Perthes disease and accept total hip replacement in our center
Key exclusion criteria (1 listed)
- infection, cannot complete follow-up
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 |
|---|---|---|
| robotic arm-assisted total hip replacementusing robotic total hip replacement in patients with Legg-Calvé-Perthes disease | Procedure or surgery | robotic arm-assisted total hip replacement |
| conventional total hip replacementapplying conventional total hip replacement in patients with Legg-Calvé-Perthes disease | Procedure or surgery | conventional total hip replacement |
Primary outcome
inclination angle
Time frame: 2 days after surgery
The inclination angle in total hip replacement (THR), also called the abduction angle , refers to the angle at which the acetabular cup component is tilted relative to the horizontal plane when viewed on an anteroposterior (AP) pelvic X-ray.
anteversion angle
Time frame: 2 days after surgery
The anteversion angle in total hip replacement (THR) refers to the forward tilt (rotation) of the acetabular cup component around its vertical axis. It determines whether the cup's opening faces more forward or backward relative to the pelvis.
Hospital for Special Surgery Score score (HSS score)
Time frame: before the surgery, 1 week after surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery
The maximum values is 100, and the minimum value is 0. Higher scores means a better outcome.
3 secondary outcomes
operation duration
Time frame: during the operation
blood loss
Time frame: during the operation
Visual Analogue Scale score (VAS score)
Time frame: before the surgery, 1 week after surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Legg-Calvé-Perthes Disease
Recruiting
Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
Osteonecrosis of the Femoral Head, Avascular Necrosis of the Femoral Head
Active, not recruiting
Early Feasibility Study of Cartilage Defect Repair
Osteoarthritis, Hip, Femoroacetabular Impingement
RecruitingPhase 2
Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
Sickle Cell Disease, Sickle Cell Anemia
RecruitingObservational study
Screening for Biomarkers of Osteonecrosis of the Femoral Head
Osteonecrosis of the Femoral Head
Active, not recruitingObservational study
Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment
Hip Dysplasia, Legg-Calvâe-Perthes Disease
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.
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 robotic arm-assisted total hip replacement and conventional total hip replacement in people with Legg-Calvé-Perthes Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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: enrolling by invitation, as of the sponsor's last update on 14 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
inclination angle (time frame: 2 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.