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

King Abdullah International Medical Research Center1 site in 1 country180 target enrollmentDecember 2010

ConditionsTibia Fracture

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tibia Fracture
Sponsor: King Abdullah International Medical Research Center
Enrollment: 180
Locations: 1
Primary Endpoint: Rate Of Malunion
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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 ®

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

December 2014

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

King Abdullah International Medical Research Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate Of Malunion

Time Frame: 6 months

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.

Secondary Outcomes

Blood Loss(during the time of surgery)
The Short Form (12) Health Score (SF-12v2®)(every 3 months till healing or 24 months)
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(6 months)