M.I.P.O. vs Intramedullary Nailing in Tibia Fractures (MINT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Tibia Fracture
• Intervention / Treatment: Procedure: Minimally Invasive Plate Osteosynthesis; Procedure: intramedullary tibial Nailing

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Central
    • Riyadh, Central, Saudi Arabia, 11426
      • Recruiting
      • King Abdullah International Medical Research Center
      • Contact: Husam A AL-Rumaih, MD; Phone Number: 14119 +96612520088; Email: rumaih@me.com
      • Contact: Sami I AL-Essia, MD; Phone Number: 14119 +96612520088; Email: saleissa@yahoo.com
      • Principal Investigator: Wael S Taha, MD
      • Sub-Investigator: Abdulaziz AL-Ammari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Investigators: Principal Investigator: Husam A AL-Rumaih, MD, National Guard Heath Affaires, Saudi Arabia; Study Director: Wael S Taha, MD, National Guard Health Affairs; Study Chair: Sami I AL-Essia, MD, National Guard Health Affairs

Publications and helpful links

Helpful Links

• King Abdullah International Medical Research Center
• The Trials webpage

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): June 23, 2011
• Last Update Submitted That Met QC Criteria: June 22, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Fractured Tibia; Expert Tibial Nail; Minimally Invasive Plate Osteosynthesis (M.I.P.O); Intramedullary Nailing; Locked Plate; distal third; 43-A
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: RC09/128