ClinicalTrials.Veeva

Menu

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

K

King Abdullah International Medical Research Center

Status

Unknown

Conditions

Tibia Fracture

Treatments

Procedure: Minimally Invasive Plate Osteosynthesis
Procedure: intramedullary tibial Nailing

Study type

Interventional

Funder types

Other

Identifiers

NCT01047826
RC09/128

Details and patient eligibility

About

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.

Full 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 ®

Enrollment

180 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

M.I.P.O. Group
Experimental group
Description:
subjects who have been randomized to the M.I.P.O. group
Treatment:
Procedure: Minimally Invasive Plate Osteosynthesis
Intramedullary Nail group
Experimental group
Description:
Subjects who have been Randomized to the I.M. group
Treatment:
Procedure: intramedullary tibial Nailing

Trial contacts and locations

1

Loading...

Central trial contact

Husam A AL-Rumaih, MD; Wael S Taha, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems