M.I.P.O. vs Intramedullary Nailing in Tibia Fractures

Study Overview
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Brief Summary
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The investigators are comparing two methods of standard treatments in distal tibial fractures. locked plating (M.I.P.O. technique) with intramedullary nailing. the investigators are hypothesizing that M.I.P.O group is superior to nailing in fractures of the distal third of the tibia.

Detailed Description
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The kind of plates the investigators are comparing are the Locked plates form Synthes ® using the minimally invasive technique vs the Expert Tibial Nail® from Synthes ®

Official Title
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Intramedullary Nailing vs. M.I.P.O. in Fractures of the Tibia a Randomized Controlled Trial

Conditions
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Tibia Fracture

Intervention / Treatment
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* Procedure: Minimally Invasive Plate Osteosynthesis
* Procedure: intramedullary tibial Nailing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females aged from 18-60 years Closed Tibia Fracture Tibia Fracture Müller AO Class 43-A Exclusion Criteria: Intra-articular Fractures Open fractures fracturesSubjects with documented Marfan's syndrome or Ehlers-Danlos syndrome or Hajdu-Cheney syndrome. Post organ transplant patients (except Cornea transplant) Subjects on immunosuppressive medications Subjects with diagnosed with Osteogenesis imperfecta Osteopetrosis Paget disease of bone Renal osteodystrophy Subjects with diagnosed neoplasms or mitotic illnesses Subjects receiving growth hormone Unable to comply with postoperative rehabilitation e.g. head injury Impending compartment syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M.I.P.O. Group<br>subjects who have been randomized to the M.I.P.O. group | Procedure: Minimally Invasive Plate Osteosynthesis<br>* Fractures well be treated with locked plates using M.I.P.O. Technique<br>* Other names: Minimally invasive percutaneous plate osteosynthesis (MIPPO);|
| Experimental: Intramedullary Nail group<br>Subjects who have been Randomized to the I.M. group | Procedure: intramedullary tibial Nailing<br>* Fractures well be fixed using intramedullary nails<br>* Other names: Expert Tibial Nail ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate Of Malunion | Any healing that occurs with any one of the following: More than 5 degree angulation in the anterior-posterior or lateral view or Rotation of more than 10 degrees or Shorting of more than 1 cm. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Short Form (12) Health Score (SF-12v2®) |  | every 3 months till healing or 24 months | 
| Blood Loss |  | during the time of surgery | 
| Radiation exposure |  | During the time of Surgery | 
| Duration of Surgery |  | During the time of Surgery | 
| Infection Rate |  | every 3 months till healing or 24 months | 
| Hospital Stay |  | After Surgery | 
| Time Of Fracture Healing | Clinical Criteria: No pain or tenderness while wight bearing or palpating the fracture site Radiological Criteria: Bridging of the fracture site in anterior-posterior and lateral views. Using these two criteria we well be able to measure the time of healing in our study subjects. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractured Tibia, Expert Tibial Nail, Minimally Invasive Plate Osteosynthesis (M.I.P.O), Intramedullary Nailing, Locked Plate, distal third, 43-A