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

Primary Purpose

Tibia Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Minimally Invasive Plate Osteosynthesis
intramedullary tibial Nailing
Sponsored by
King Abdullah International Medical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibia Fracture focused on measuring Fractured Tibia, Expert Tibial Nail, Minimally Invasive Plate Osteosynthesis (M.I.P.O), Intramedullary Nailing, Locked Plate, distal third, 43-A

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Abdullah International Medical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

M.I.P.O. Group

Intramedullary Nail group

Arm Description

subjects who have been randomized to the M.I.P.O. group

Subjects who have been Randomized to the I.M. group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Short Form (12) Health Score (SF-12v2®)
Blood Loss
Radiation exposure
Duration of Surgery
Infection Rate
Hospital Stay
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.

Full Information

First Posted
January 12, 2010
Last Updated
June 22, 2011
Sponsor
King Abdullah International Medical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01047826
Brief Title
M.I.P.O. vs Intramedullary Nailing in Tibia Fractures
Acronym
MINT
Official Title
Intramedullary Nailing vs. M.I.P.O. in Fractures of the Tibia a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
King Abdullah International Medical Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 ®

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibia Fracture
Keywords
Fractured Tibia, Expert Tibial Nail, Minimally Invasive Plate Osteosynthesis (M.I.P.O), Intramedullary Nailing, Locked Plate, distal third, 43-A

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M.I.P.O. Group
Arm Type
Experimental
Arm Description
subjects who have been randomized to the M.I.P.O. group
Arm Title
Intramedullary Nail group
Arm Type
Experimental
Arm Description
Subjects who have been Randomized to the I.M. group
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Plate Osteosynthesis
Other Intervention Name(s)
Minimally invasive percutaneous plate osteosynthesis (MIPPO)
Intervention Description
Fractures well be treated with locked plates using M.I.P.O. Technique
Intervention Type
Procedure
Intervention Name(s)
intramedullary tibial Nailing
Other Intervention Name(s)
Expert Tibial Nail ®
Intervention Description
Fractures well be fixed using intramedullary nails
Primary Outcome Measure Information:
Title
Rate Of Malunion
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The Short Form (12) Health Score (SF-12v2®)
Time Frame
every 3 months till healing or 24 months
Title
Blood Loss
Time Frame
during the time of surgery
Title
Radiation exposure
Time Frame
During the time of Surgery
Title
Duration of Surgery
Time Frame
During the time of Surgery
Title
Infection Rate
Time Frame
every 3 months till healing or 24 months
Title
Hospital Stay
Time Frame
After Surgery
Title
Time Of Fracture Healing
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 Subjects with diagnosed neoplasms or mitotic illnesses Subjects receiving growth hormone Unable to comply with postoperative rehabilitation e.g. head injury Impending compartment syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Husam A AL-Rumaih, MD
Phone
+96612520088
Ext
14119
Email
rumaih@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wael S Taha, MD
Phone
+96612520088
Ext
14117
Email
waelstaha@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Husam A AL-Rumaih, MD
Organizational Affiliation
National Guard Heath Affaires, Saudi Arabia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wael S Taha, MD
Organizational Affiliation
National Guard Health Affairs
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sami I AL-Essia, MD
Organizational Affiliation
National Guard Health Affairs
Official's Role
Study Chair
Facility Information:
Facility Name
King Abdullah International Medical Research Center
City
Riyadh
State/Province
Central
ZIP/Postal Code
11426
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Husam A AL-Rumaih, MD
Phone
+96612520088
Ext
14119
Email
rumaih@me.com
First Name & Middle Initial & Last Name & Degree
Sami I AL-Essia, MD
Phone
+96612520088
Ext
14119
Email
saleissa@yahoo.com
First Name & Middle Initial & Last Name & Degree
Wael S Taha, MD
First Name & Middle Initial & Last Name & Degree
Abdulaziz AL-Ammari, MD

12. IPD Sharing Statement

Links:
URL
http://www.kaimrc.med.sa/
Description
King Abdullah International Medical Research Center
URL
http://www.minttrial.com
Description
The Trials webpage

Learn more about this trial

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

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