To study the safety and performance of implants used for radius head replacement in patients with elbow fracture

Post Market Clinical Follow-up (PMCF) study to evaluate the safety and performance of Radial Head System - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/01/100841

Enrollment

Registered

2026-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: S479- Crushing injury of shoulder and upper arm, unspecified arm

Interventions

Intervention1: Radial head replacement: Radial head replacement shall be done at baseline and patients shall be followed up for two years. Control Intervention1: None: N.A.

Eligibility

Inclusion criteria

Inclusion criteria: Patients with non-reconstructible radial head fractures.

Exclusion criteria

Exclusion criteria: 1. Patients will known metabolic bone disease. 2. Patients having inadequate tissue coverage over the operative site. 3. Suspected or documented allergy or intolerance to implant materials. 4. Patients with symptomatic arthritis. 5. Severely comminuted fractures. 6. Prominent neurological condition that would interfere with physiotherapy. 7. Known psychiatric disease that would interfere with study participation. 8. Pregnant women or those planning pregnancy.

Design outcomes

Primary

Measure	Time frame
1. Rate of implant survivorship. 2. Complications including SAEs. Timepoint: 6 Week 3 Month 6 Month 12 Month 24 Month	—

Secondary

Measure	Time frame
1. Improvement in patient reported outcomes. 2. Range of motion.Timepoint: 6 Week 3 Month 6 Month 12 Month 24 Month	—

Countries

India

Contacts

Public ContactDr Mohd Aslam

Auxein Medical Pvt Ltd

m.aslam@auxeinmedical.com7419660141

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026