A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP

Recruiting now

Conditions studied: Hereditary Spastic Paraplegia

In brief

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 deformities. Our goal is to systematically summarize clinical experiences to guide practice and ultimately optimize patient outcomes. The core research objectives include elucidating: 1. the long-term efficacy of foot deformity correction procedures; 2. the optimal timing for surgical intervention; 3. the establishment of objective evaluation criteria to guide therapeutic decision-making.

Key facts

Study ID

NCT06936163

Run by

Shanghai 6th People's Hospital

People needed

100

Starts

2025-03-01

Expected to finish

2027-04-30

Last updated by the study team

2025-04-20

Who can join

Age: 10 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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