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
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2010
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 23, 2011
October 1, 2010
3 years
January 12, 2010
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
M.I.P.O. Group
EXPERIMENTALsubjects who have been randomized to the M.I.P.O. group
Intramedullary Nail group
EXPERIMENTALSubjects who have been Randomized to the I.M. group
Interventions
Fractures well be treated with locked plates using M.I.P.O. Technique
Fractures well be fixed using intramedullary nails
Eligibility Criteria
You may qualify if:
- Males and Females aged from 18-60 years
- Closed Tibia Fracture
- Tibia Fracture Müller AO Class 43-A
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Abdullah International Medical Research Center
Riyadh, Central, 11426, Saudi Arabia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 12, 2010
First Posted
January 13, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
June 23, 2011
Record last verified: 2010-10