Functional outcome of Titanium elastic nail in fracture shaft region of long bones in pediatrics age group (6-14yrs)

Functional outcome of TENS (Titanium Elastic Nailing System) in diaphyseal fracture of long bones in pediatrics age group (6-14 years). - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060297

Enrollment

Registered

2023-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: T148- Other injury of unspecified body region

Interventions

Intervention1: Titanium Elastic Nailing System Fixation: Titanium Elastic Nail fixation in diaphyseal fracture of long bones in pediatrics age group (6-14 years). Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 6 to 14 years 2. Both males and females 3. All closed fracture 4. Open fracture up to Gustilo-Anderson Grade II 5. Fresh fracture 6. Patients willing to form informed consent

Exclusion criteria

Exclusion criteria: 1. Complicated fracture (associated neurovascular compromise) 2. Open fracture with Gustilo-Anderson Grade III 3. Patient refusal to give informed consent

Design outcomes

Primary

Measure	Time frame
Radiological features of union shall be looked for, such as, gradual disappearance of fracture line and cortical continuity. Functional outcome as assessed by Flynn et al Scoring CriteriaTimepoint: After discharge, patients will follow up after every 2 weeks up to 2 months & subsequently at monthly intervals. Radiological features of union shall be looked for, such as, gradual disappearance of fracture line and cortical continuity in 6 months. Functional outcome as assessed by Flynn et al Scoring Criteria, for a time of 6 months.	—

Measure

Time frame

Radiological features of union shall be looked for, such as, gradual disappearance of fracture line and cortical continuity. Functional outcome as assessed by Flynn et al Scoring CriteriaTimepoint: After discharge, patients will follow up after every 2 weeks up to 2 months & subsequently at monthly intervals. Radiological features of union shall be looked for, such as, gradual disappearance of fracture line and cortical continuity in 6 months. Functional outcome as assessed by Flynn et al Scoring Criteria, for a time of 6 months.

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Secondary

Measure	Time frame
Complications such as non-union, malunion, hardware prominence, soft tissue irritation, superficial skin infection, etc. shall be assessed along with the incidence of implant removal shall be assessed along with its cause.Timepoint: After discharge, patients will follow up after every 2 weeks up to 2 months & subsequently at monthly intervals. Complications such as non-union, malunion, hardware prominence, soft tissue irritation, superficial skin infection, etc. shall be assessed along with the incidence of implant removal shall be assessed along with its cause in a span of 6 months.	—

Measure

Time frame

Complications such as non-union, malunion, hardware prominence, soft tissue irritation, superficial skin infection, etc. shall be assessed along with the incidence of implant removal shall be assessed along with its cause.Timepoint: After discharge, patients will follow up after every 2 weeks up to 2 months & subsequently at monthly intervals. Complications such as non-union, malunion, hardware prominence, soft tissue irritation, superficial skin infection, etc. shall be assessed along with the incidence of implant removal shall be assessed along with its cause in a span of 6 months.

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Countries

India

Contacts

Public ContactDr Himanshu

Pt. B.D Sharma PGIMS Rohtak

HIMANSHUESHU89@GMAIL.COM8950606078

Outcome results

None listed

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