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

Tibia Fracture Clinical Trial

— MINT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01047826
• Other study ID #: RC09/128
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2010
• Last updated: June 22, 2011
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: October 2010
• Source: King Abdullah International Medical Research Center
• Contact: Husam A AL-Rumaih, MD
• Phone: +96612520088
• Email: rumaih[@]me.com
• Is FDA regulated: No
• Health authority: Saudi Arabia: Research Advisory Council
• Study type: Interventional

Clinical Trial 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.

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 ®

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibia Fracture
• Tibial Fractures

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Saudi Arabia	King Abdullah International Medical Research Center	Riyadh	Central

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The Short Form (12) Health Score (SF-12v2®)		every 3 months till healing or 24 months	No
Secondary	Blood Loss		during the time of surgery	No
Secondary	Radiation exposure		During the time of Surgery	No
Secondary	Duration of Surgery		During the time of Surgery	No
Secondary	Infection Rate		every 3 months till healing or 24 months	No
Secondary	Hospital Stay		After Surgery	No
Secondary	Time Of Fracture Healing	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.	6 months	No

External Links

•   King Abdullah International Medical Research Center
•   The Trials webpage