Status:
RECRUITING
A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP
Lead Sponsor:
Shanghai 6th People's Hospital
Conditions:
Hereditary Spastic Paraplegia
Eligibility:
All Genders
10-45 years
Brief Summary
Through a prospective cohort study, we aim to dynamically evaluate the long-term benefits and risks associated with surgical interventions for hereditary spastic paraparesis (HSP) accompanied by foot ...
Detailed Description
Hereditary spastic paraplegia (HSP) is a neurodegenerative disorder characterized by axonal degeneration of the corticospinal tract. This degeneration often leads to foot deformities such as equinovar...
Eligibility Criteria
Inclusion
- Age: 10 to 45 years old.
- Clinically and molecular genetically confirmed diagnosis of hereditary spastic paraparesis (HSP) with either isolated Achilles tendon contracture or equinovarus cavus deformity.
- Radiographic (X-ray) or computed tomography (CT) evidence confirming the presence of isolated Achilles tendon contracture or equinovarus cavus deformity.
- Signed informed consent form by patients/legal guardians for voluntary participation in the clinical study, with full comprehension of and commitment to study protocols .
- Suboptimal response to standard conservative treatments (pharmacotherapy and/or rehabilitative exercise programs) with progressive worsening of gait abnormalities and foot deformities .
- Functional impairment secondary to isolated Achilles tendon contracture or equinovarus cavus deformity, manifesting as ambulatory pain, frequent falls, and significant quality-of-life limitations.
- Ability to ambulate barefoot for 10 meters independently or with assistive devices.
Exclusion
- Prior history of foot and ankle orthopedic surgery.
- Severe cognitive impairment or an inability to adhere to postoperative protocols and functional assessments.
- Isolated Achilles tendon contracture or equinovarus cavus deformity resulting from definitive etiologies (e.g., diabetes mellitus, infectious arthritis, or inflammatory arthropathy).
- Significant peripheral vascular disease or clinically significant unstable medical conditions, including malignancies, hematologic disorders, and cardiopulmonary, hepatic, or renal insufficiency.
- Coexisting neurodegenerative or neuromuscular disorders that are unrelated to hereditary spastic paraplegia (HSP).
- Poor compliance with study requirements or other contraindications to participation in clinical trials.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06936163
Start Date
March 1 2025
End Date
April 30 2027
Last Update
April 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 213000