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

Not Applicable

• Conditions: Tibia Fracture
• Interventions: Procedure: intramedullary tibial Nailing; Procedure: Minimally Invasive Plate Osteosynthesis

• Registration Number: NCT01047826
• Lead Sponsor: King Abdullah International Medical Research Center

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 ®

Study Timeline

• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Status Verified: 2010-10
• Study Start: 2010-12
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramedullary Nail group	intramedullary tibial Nailing	Subjects who have been Randomized to the I.M. group
M.I.P.O. Group	Minimally Invasive Plate Osteosynthesis	subjects who have been randomized to the M.I.P.O. group

Primary Outcome Measures

Name	Time	Method
Rate Of Malunion	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 Outcome Measures

Name	Time	Method
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	6 months	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.

Trial Locations

Locations (1)

King Abdullah International Medical Research Center; 🇸🇦 Riyadh, Central, Saudi Arabia