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

NCT ID: NCT01047826

Last Updated: 2011-06-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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 ®

Conditions

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Tibia Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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M.I.P.O. Group

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

Group Type EXPERIMENTAL

Minimally Invasive Plate Osteosynthesis

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

intramedullary tibial Nailing

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

intramedullary tibial Nailing

Fractures well be fixed using intramedullary nails

Intervention Type PROCEDURE

Other Intervention Names

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Minimally invasive percutaneous plate osteosynthesis (MIPPO) Expert Tibial Nail ®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Husam A AL-Rumaih, MD

Role: CONTACT

+96612520088 ext. 14119

Wael S Taha, MD

Role: CONTACT

+96612520088 ext. 14117

Facility Contacts

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Husam A AL-Rumaih, MD

Role: primary

+96612520088 ext. 14119

Sami I AL-Essia, MD

Role: backup

+96612520088 ext. 14119

Related Links

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http://www.minttrial.com

The Trials webpage

Other Identifiers

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RC09/128

Identifier Type: -

Identifier Source: org_study_id

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