Comparison of Robotic Arm-assisted THA and Conventional Manual THA in Patients With Legg-Calvé-Perthes Disease: a Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- inclination angle
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with Legg-Calvé-Perthes disease and accept total hip replacement in our center
Exclusion Criteria
- •infection, cannot complete follow-up
Arms & Interventions
conventional total hip replacement
applying conventional total hip replacement in patients with Legg-Calvé-Perthes disease
Intervention: conventional total hip replacement (Procedure)
robotic arm-assisted total hip replacement
applying robotic arm-assisted total hip replacement in patients with Legg-Calvé-Perthes disease
Intervention: robotic arm-assisted total hip replacement (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- blood loss(during the operation)
- operation duration(during the operation)
- Visual Analogue Scale score (VAS score)(before the surgery, 1 week after surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery)
Investigators
Xiang Zhao, MD
Principal Investigator
Second Affiliated Hospital, School of Medicine, Zhejiang University