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Evaluation of Hindfoot Nailing with and without Additional Screw

Comparison of Hindfoot Nailing with or without Augmentation-A Pragmatic double blind randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082009
Enrollment
40
Registered
2025-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system

Interventions

Intervention1: Hindfoot nailing : Hindfoot arthrodesis (fusion of the ankle and subtalar joints) will be performed with the hindfoot nail alone Control Intervention1: Hindfoot nailing with augmentati

Sponsors

Dr Siddhartha Sharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. Male or Female, between 18 - 70 years who are taken up for hindfoot fusion by hindfoot nailing system. ii. Subject willing to give consent form.

Exclusion criteria

Exclusion criteria: I. Specific contraindications which include i. Dysvascular limb ii. Active infection iii. Insufficient plantar pad II. Infection, local to the operative site. III. Signs of local inflammation. IV. Patient susceptibility to allergic reaction to the components of the alloy, the implant is manufactured from. V. Mental illness or schizophrenia, which may cause patients to ignore the limitations and precautions of the implanted material, leading to implants fracture and complication. VI. Alcohol or drug addict VII. Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, the amount of mechanical fixation. VIII. Symptomatic Arthritis IX. Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition. X. Any time implant utilization would interfere with anatomical structures or expected physiological performance. XI. Any patient unwilling to cooperate with the post-operative instructions.

Design outcomes

Primary

MeasureTime frame
Arthrodesis rates , EQ5D Scores , MOxFQ ScoreTimepoint: 1 year

Secondary

MeasureTime frame
Time to Union Complications Patient satisfactionTimepoint: 1 Year

Countries

India

Contacts

Public ContactSiddhartha Sharma

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

sids82@gmail.com9988793537

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026