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Enrolling by invitationNCT07122323Updated Aug 14, 2025

Robotic Arm-assisted THA Vs. Conventional THA in Legg-Calvé-Perthes Disease

An interventional study of robotic arm-assisted total hip replacement and conventional total hip replacement in Legg-Calvé-Perthes Disease, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Legg-Calvé-Perthes Disease

Keywords

  • MAKO
  • Legg-Calvé-Perthes disease
  • flat hip
03

In context

Legg-Calve-Perthes Disease

31 studies on the registry are indexed under Legg-Calve-Perthes Disease; 7 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 20 interventional studies indexed under Legg-Calve-Perthes Disease.

Browse Legg-Calve-Perthes Disease studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with Legg-Calvé-Perthes disease and accept total hip replacement in our center

Exclusion criteria

Exclusion Criteria:

  • infection, cannot complete follow-up
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    conventional total hip replacement

    applying conventional total hip replacement in patients with Legg-Calvé-Perthes disease

    Procedure: conventional total hip replacement

  • Experimental
    robotic arm-assisted total hip replacement

    applying robotic arm-assisted total hip replacement in patients with Legg-Calvé-Perthes disease

    Procedure: robotic arm-assisted total hip replacement

Interventions

  • Procedurerobotic arm-assisted total hip replacement

    using robotic total hip replacement in patients with Legg-Calvé-Perthes disease

  • Procedureconventional total hip replacement

    applying conventional total hip replacement in patients with Legg-Calvé-Perthes disease

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 days after surgery

  2. 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.

    Time frame: 2 days after surgery

  3. 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.

    Time frame: before the surgery, 1 week after surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery

Secondary outcomes

  1. operation duration

    The operation duration (also called operative time or surgical time ) refers to the total time taken to complete a surgical procedure.

    Time frame: during the operation

  2. blood loss

    The amount of blood loss during the surgery.

    Time frame: during the operation

  3. Visual Analogue Scale score (VAS score)

    The maximum value is 10, and the minimum value is 0. Lower score means a better outcome.

    Time frame: before the surgery, 1 week after surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery

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Study locations

1 site
  • Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07122323
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Xiang Zhao, MD (Principal Investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University) — Principal investigator
First posted
Aug 14, 2025
Start date
Jul 28, 2025
Primary completion
Jul 28, 2027 (estimated)
Completion
Jul 28, 2027 (estimated)
Last update
Aug 14, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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