Evaluating surgical treatment for foot deformities in hereditary spastic paraplegia

Surgical Outcomes of Foot Deformities in Hereditary Spastic Paraplegia: A Prospective Cohort Study

This study is testing how well surgery can help people with hereditary spastic paraplegia and foot deformities feel and function better over two years.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 10 Years to 45 Years
• Sex: All
• Sponsor: Shanghai 6th People's Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06936163 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 10-45 with confirmed hereditary spastic paraplegia and specific foot deformities that have not responded to conservative treatments.

Not a fit: Patients with non-progressive foot deformities or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical strategies that enhance mobility and quality of life for patients with hereditary spastic paraplegia.

How similar studies have performed: While there is limited data on similar studies, the approach of evaluating surgical outcomes for HSP-related deformities is relatively novel and may provide valuable insights.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• 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

Conditions Hereditary Spastic Paraplegia; foot deformities