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Clinical Trials/CTRI/2025/03/081834
CTRI/2025/03/081834
Not yet recruiting
Phase 3 4

Outcome Analysis of Factors Affecting Fracture Healing in Immediate versus Delayed Intramedullary Nailing for Compound Fractures of Tibial Shaft.

Datta Meghe Institute of higher education and research1 site in 1 country30 target enrollmentStarted: March 16, 2025Last updated:

Overview

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Datta Meghe Institute of higher education and research
Enrollment
30
Locations
1
Primary Endpoint
Fracture healing in immediate and delayed intramedullary nailing for compound fractures of tibia shaft

Overview

Brief Summary

My purpose of study is to evaluate healing of compound tibia fractures when managed with immediate and delayed intramedullary nailing. Upon evaluation of the factors prevailing during the course of management, after discharge and during follow ups, these factors will be studied and formulated into constructive data tabulations and hence it will be summarised which set of patients had better outcome in terms of fracture healing, pain relief, early mobilisation and resumption of day to day activities.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients of compound Tibia shaft fractures (Until Gustilo Anderson classification grade 3C) Patients who are willing to take part in study after informed consent.

Exclusion Criteria

  • All Pathological fractures of tibia Tumors Deformity Unwilling Patients.

Outcomes

Primary Outcomes

Fracture healing in immediate and delayed intramedullary nailing for compound fractures of tibia shaft

Time Frame: Post op day 0 | 3 months +/- 1 week post op | 6 months +/- 1 week post op | 9 months +/- 1 week post op

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Datta Meghe Institute of higher education and research
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Samarth Kashyap

Jawaharlal nehru medical college

Study Sites (1)

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