Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2010-12-31
2014-12-31
Brief Summary
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the investigators are hypothesizing that M.I.P.O group is superior to nailing in fractures of the distal third of the tibia.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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M.I.P.O. Group
subjects who have been randomized to the M.I.P.O. group
Minimally Invasive Plate Osteosynthesis
Fractures well be treated with locked plates using M.I.P.O. Technique
Intramedullary Nail group
Subjects who have been Randomized to the I.M. group
intramedullary tibial Nailing
Fractures well be fixed using intramedullary nails
Interventions
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Minimally Invasive Plate Osteosynthesis
Fractures well be treated with locked plates using M.I.P.O. Technique
intramedullary tibial Nailing
Fractures well be fixed using intramedullary nails
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Closed Tibia Fracture
* Tibia Fracture Müller AO Class 43-A
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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King Abdullah International Medical Research Center
OTHER
Responsible Party
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King Abdullah International Medical Research Center
Principal Investigators
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Husam A AL-Rumaih, MD
Role: PRINCIPAL_INVESTIGATOR
National Guard Heath Affaires, Saudi Arabia
Wael S Taha, MD
Role: STUDY_DIRECTOR
National Guard Health Affairs
Sami I AL-Essia, MD
Role: STUDY_CHAIR
National Guard Health Affairs
Locations
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King Abdullah International Medical Research Center
Riyadh, Central, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The Trials webpage
Other Identifiers
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RC09/128
Identifier Type: -
Identifier Source: org_study_id
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