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

This study is currently recruiting participants.
Verified October 2010 by King Abdullah International Medical Research Center
Sponsor:
Information provided by:
King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier:
NCT01047826
First received: January 12, 2010
Last updated: June 22, 2011
Last verified: October 2010
  Purpose

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.


Condition Intervention
Tibia Fracture
Procedure: Minimally Invasive Plate Osteosynthesis
Procedure: intramedullary tibial Nailing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intramedullary Nailing vs. M.I.P.O. in Fractures of the Tibia a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by King Abdullah International Medical Research Center:

Primary Outcome Measures:
  • Rate Of Malunion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • The Short Form (12) Health Score (SF-12v2®) [ Time Frame: every 3 months till healing or 24 months ] [ Designated as safety issue: No ]
  • Blood Loss [ Time Frame: during the time of surgery ] [ Designated as safety issue: No ]
  • Radiation exposure [ Time Frame: During the time of Surgery ] [ Designated as safety issue: No ]
  • Duration of Surgery [ Time Frame: During the time of Surgery ] [ Designated as safety issue: No ]
  • Infection Rate [ Time Frame: every 3 months till healing or 24 months ] [ Designated as safety issue: No ]
  • Hospital Stay [ Time Frame: After Surgery ] [ Designated as safety issue: No ]
  • Time Of Fracture Healing [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 180
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Expert Tibial Nail ®

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 ®

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Subjects with diagnosed neoplasms or mitotic illnesses
  • Subjects receiving growth hormone
  • Unable to comply with postoperative rehabilitation e.g. head injury
  • Impending compartment syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047826

Contacts
Contact: Husam A AL-Rumaih, MD +96612520088 ext 14119 rumaih@me.com
Contact: Wael S Taha, MD +96612520088 ext 14117 waelstaha@gmail.com

Locations
Saudi Arabia
King Abdullah International Medical Research Center Recruiting
Riyadh, Central, Saudi Arabia, 11426
Contact: Husam A AL-Rumaih, MD    +96612520088 ext 14119    rumaih@me.com   
Contact: Sami I AL-Essia, MD    +96612520088 ext 14119    saleissa@yahoo.com   
Principal Investigator: Wael S Taha, MD         
Sub-Investigator: Abdulaziz AL-Ammari, MD         
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Husam A. AL-Rumaih/Dr, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT01047826     History of Changes
Other Study ID Numbers: RC09/128
Study First Received: January 12, 2010
Last Updated: June 22, 2011
Health Authority: Saudi Arabia: Research Advisory Council

Keywords provided by King Abdullah International Medical Research Center:
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:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 23, 2014