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

NCT ID: NCT06936163

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-04-30

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 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.

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 equinovarus, cavus foot, and Achilles tendon contracture, which result from lower limb spasticity and muscular imbalance. These deformities result in gait abnormalities, uneven plantar pressure distribution, and secondary osteoarticular damage, which significantly impair motor function and quality of life. Surgical correction serves as the primary intervention to address fixed deformities and delay disease progression.This prospective, open-label, single-center study aims to evaluate the long-term functional outcomes of surgical treatment for HSP-related foot deformities, determine the optimal timing for surgical intervention, and establish objective evaluation criteria. Over a 2-year period, 100 patients aged 10-45 years with HSP-confirmed isolated Achilles tendon contracture or equinovarus cavus foot deformity will be enrolled in the study. Eligible patients must exhibit progressive deformity refractory to conservative therapy, accompanied by walking pain, frequent falls, and significant quality-of-life impairment. They must also retain the ability to walk independently or with assistive devices for at least 10 meters. All participants will undergo regular clinical assessments.

Conditions

Hereditary Spastic Paraplegia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HSP patients (ages 10 to 45) with foot deformities unresponsive to conservative therapy

Patients aged 10 to 45 years who have been diagnosed with isolated Achilles tendon contracture or equinovarus cavus deformity due to hereditary spastic paraparesis (HSP) will be recruited for the study. Eligible participants must have undergone standard conservative treatments, including pharmacological therapy or rehabilitation exercises, but have demonstrated a poor response or progressive worsening of gait disturbances and foot deformities, and be capable of walking barefoot for 10 meters, with or without the use of assistive devices.

No interventions assigned to this group

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Cao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Cao, phD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Locations

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Cao, phD

Role: CONTACT

caoli2000@yeah.net

+86 21 64369263

Wo tu Tian, phD

Role: CONTACT

wotu_tian@163.com

+86 21 64369181

Facility Contacts

Wo tu Tian, phD

Role: primary

wotu_tian@163.com

02164369181

Other Identifiers

2025-KY-034(K)

Identifier Type: -

Identifier Source: org_study_id