Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 ®
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M.I.P.O. Group | Experimental | subjects who have been randomized to the M.I.P.O. group |
|
| Intramedullary Nail group | Experimental | Subjects who have been Randomized to the I.M. group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Plate Osteosynthesis | Procedure | Fractures well be treated with locked plates using M.I.P.O. Technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Short Form (12) Health Score (SF-12v2®) | every 3 months till healing or 24 months | |
| Blood Loss | during the time of surgery | |
| Radiation exposure |
Not provided
Inclusion Criteria:
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
Subjects with diagnosed neoplasms or mitotic illnesses
Subjects receiving growth hormone
Unable to comply with postoperative rehabilitation e.g. head injury
Impending compartment syndrome
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Husam A AL-Rumaih, MD | Contact | +96612520088 | 14119 | rumaih@me.com |
| Wael S Taha, MD | Contact | +96612520088 | 14117 | waelstaha@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Husam A AL-Rumaih, MD | National Guard Heath Affaires, Saudi Arabia | Principal Investigator |
| Wael S Taha, MD | National Guard Health Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdullah International Medical Research Center | Recruiting | Riyadh | Central | 11426 | Saudi Arabia |
Not provided
| Label | URL |
|---|---|
| The Trials webpage | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| intramedullary tibial Nailing | Procedure | Fractures well be fixed using intramedullary nails |
|
|
| During the time of Surgery |
| Duration of Surgery | During the time of Surgery |
| Infection Rate | every 3 months till healing or 24 months |
| Hospital Stay | After Surgery |
| 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 |
| Sami I AL-Essia, MD |
| National Guard Health Affairs |
| Study Chair |