Evaluating surgical treatment for foot deformities in hereditary spastic paraplegia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to assess the long-term benefits and risks of surgical interventions for foot deformities associated with hereditary spastic paraplegia (HSP). It will enroll 100 patients aged 10-45 years who have confirmed HSP and specific foot deformities, evaluating their functional outcomes over a two-year period. The study will focus on determining the optimal timing for surgery and establishing objective criteria for evaluating treatment effectiveness. Regular clinical assessments will be conducted to monitor patient progress and outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 10 to 45 years old.
2. Clinically and molecular genetically confirmed diagnosis of hereditary spastic paraparesis (HSP) with either isolated Achilles tendon contracture or equinovarus cavus deformity.
3. Radiographic (X-ray) or computed tomography (CT) evidence confirming the presence of isolated Achilles tendon contracture or equinovarus cavus deformity.
4. Signed informed consent form by patients/legal guardians for voluntary participation in the clinical study, with full comprehension of and commitment to study protocols .
5. Suboptimal response to standard conservative treatments (pharmacotherapy and/or rehabilitative exercise programs) with progressive worsening of gait abnormalities and foot deformities .
6. Functional impairment secondary to isolated Achilles tendon contracture or equinovarus cavus deformity, manifesting as ambulatory pain, frequent falls, and significant quality-of-life limitations.
7. Ability to ambulate barefoot for 10 meters independently or with assistive devices.

Exclusion Criteria:

1. Prior history of foot and ankle orthopedic surgery.
2. Severe cognitive impairment or an inability to adhere to postoperative protocols and functional assessments.
3. Isolated Achilles tendon contracture or equinovarus cavus deformity resulting from definitive etiologies (e.g., diabetes mellitus, infectious arthritis, or inflammatory arthropathy).
4. Significant peripheral vascular disease or clinically significant unstable medical conditions, including malignancies, hematologic disorders, and cardiopulmonary, hepatic, or renal insufficiency.
5. Coexisting neurodegenerative or neuromuscular disorders that are unrelated to hereditary spastic paraplegia (HSP).
6. Poor compliance with study requirements or other contraindications to participation in clinical trials.

Where it's running

• Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Li Cao, phD — Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Study coordinator: Li Cao, phD
• Email: caoli2000@yeah.net
• Phone: +86 21 64369263

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.