Safety assessment of plates used for ankle fracture treatment

A Prospective Single-Arm Longitudinal Post Market Clinical Follow-up Study to Evaluate the Safety and Performance of the Ankle Plating System - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/04/066172

Enrollment

Registered

2024-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: S990- Physeal fracture of calcaneus

Interventions

Intervention1: Ankle plate system: Ankle plates will be used for ankle fracture fixation. The duration of intervention is one year. Control Intervention1: None: None

Eligibility

Inclusion criteria

Inclusion criteria: Patients presenting to Orthopaedic emergency/ OPD with Ankle fracture which need internal fixation will be included in the study.

Exclusion criteria

Exclusion criteria: Infection (local or Systemic) Acute or Chronic Inflammation to the operative site. Uncontrolled Seizure disorder/ Epilepsy Patients with known history of metal allergies Psychiatric patient Patients with life-threatening conditions Chronic Alchololic/Smoker Associated other fractures which may interfere the rehabilitation and timely surgical fixation. Female participant who is pregnant or planning pregnancy during the course of the study.

Design outcomes

Primary

Measure	Time frame
Radiologic evaluation by radiographs to calculate mean time to achieve bone union.Timepoint: 6 weeks 3 6 and 12 months	—

Secondary

Measure	Time frame
To assess implant related adverse events and their frequency.Timepoint: 6 weeks, 3, 6, and 12 months	—

Countries

India

Contacts

Public ContactMr Gaurav Luthra

Auxein Medical Private Limited

clinical2@auxeinmedical.com7419660141

Outcome results

None listed

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