NCT01047826.

Trial name or title	Intramedullary nailing vs. M.I.P.O. in fractures of the tibia; a randomised controlled trial
Methods	Randomised controlled trial
Participants	Inclusion criteria: Males and females aged from 18 to 60 years Closed tibia fracture Tibia fracture Müller AO Class 43‐A Exclusion criteria: Intra‐articular fractures Open fractures Individuals with documented Marfan's syndrome or Ehlers‐Danlos syndrome or Hajdu‐Cheney syndrome. Postorgan transplant recipients (except corneal transplant) Individuals on immunosuppressive medications Individuals diagnosed with osteogenesis imperfecta osteopetrosis Paget disease of bone renal osteodystrophy Individuals diagnosed with neoplasms or mitotic illnesses Individuals receiving growth hormone Individuals unable to comply with postoperative rehabilitation e.g. head injury Individuals with impending compartment syndrome
Interventions	1. Minimally invasive percutaneous osteosynthesis (MIPO) using locked plates 2. Intramedullary nail group using the Expert Tibial Nail
Outcomes	Primary outcome measures: 1. Rate of malunion (time frame: 6 months) 2. 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 shortening of more than 1 cm Secondary outcome measures: 1. Short Form (12) Health Score (SF‐12v2®) (time frame: every 3 months until healing or 24 months) 2. Blood loss (time frame: during the time of surgery) 3. Radiation exposure (time frame: during the time of surgery) 4. Duration of surgery 5. Infection rate (time frame: every 3 months until healing or 24 months) 6. Hospital stay (time frame: after surgery) 7. Time of fracture healing (time frame: 6 months) 8. Clinical criteria: no pain or tenderness while weight bearing or palpating the fracture site. 9. Radiological criteria: bridging of the fracture site in anterior‐posterior and lateral views. Trialists will use these two criteria to measure healing time
Starting date	Start date: December 2010 Estimated completion date: December 2014
Contact information	Principal Investigator: Husam A AL‐Rumaih, MD (Saudi Arabia)  +96612520088 ext 14119   rumaih@me.com
Notes	Estimated enrolment: 180 Status unknown (2/12/2014)