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

Intramedullary Nailing vs. M.I.P.O. in Fractures of the Tibia a Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01047826

Acronym

MINT

Enrollment

180

Registered

2010-01-13

Start date

2010-12-31

Completion date

2014-12-31

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibia Fracture

Keywords

Fractured Tibia, Expert Tibial Nail, Minimally Invasive Plate Osteosynthesis (M.I.P.O), Intramedullary Nailing, Locked Plate, distal third, 43-A

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 ®

Interventions

PROCEDUREMinimally Invasive Plate Osteosynthesis

Fractures well be treated with locked plates using M.I.P.O. Technique

PROCEDUREintramedullary tibial Nailing

Fractures well be fixed using intramedullary nails

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Rate Of Malunion	6 months	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

Measure	Time frame	Description
Blood Loss	during the time of surgery	—
Radiation exposure	During the time of Surgery	—
Duration of Surgery	During the time of Surgery	—
The Short Form (12) Health Score (SF-12v2®)	every 3 months till healing or 24 months	—
Hospital Stay	After Surgery	—
Time Of Fracture Healing	6 months	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.
Infection Rate	every 3 months till healing or 24 months	—

Countries

Saudi Arabia

Contacts

Primary ContactHusam A AL-Rumaih, MD

rumaih@me.com+96612520088

Backup ContactWael S Taha, MD

waelstaha@gmail.com+96612520088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026