M.I.P.O. vs Intramedullary Nailing in Tibia Fractures (MINT)
This study is currently recruiting participants.
Verified October 2010 by King Abdullah International Medical Research Center
Sponsor:
King Abdullah International Medical Research Center
Information provided by:
King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier:
NCT01047826
First received: January 12, 2010
Last updated: June 22, 2011
Last verified: October 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Tibia Fracture |
Procedure: Minimally Invasive Plate Osteosynthesis Procedure: intramedullary tibial Nailing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intramedullary Nailing vs. M.I.P.O. in Fractures of the Tibia a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by King Abdullah International Medical Research Center:
Primary Outcome Measures:
- Rate Of Malunion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 Outcome Measures:
- The Short Form (12) Health Score (SF-12v2®) [ Time Frame: every 3 months till healing or 24 months ] [ Designated as safety issue: No ]
- Blood Loss [ Time Frame: during the time of surgery ] [ Designated as safety issue: No ]
- Radiation exposure [ Time Frame: During the time of Surgery ] [ Designated as safety issue: No ]
- Duration of Surgery [ Time Frame: During the time of Surgery ] [ Designated as safety issue: No ]
- Infection Rate [ Time Frame: every 3 months till healing or 24 months ] [ Designated as safety issue: No ]
- Hospital Stay [ Time Frame: After Surgery ] [ Designated as safety issue: No ]
- Time Of Fracture Healing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 180 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: M.I.P.O. Group
subjects who have been randomized to the M.I.P.O. group
|
Procedure: Minimally Invasive Plate Osteosynthesis
Fractures well be treated with locked plates using M.I.P.O. Technique
Other Name: Minimally invasive percutaneous plate osteosynthesis (MIPPO)
|
|
Experimental: Intramedullary Nail group
Subjects who have been Randomized to the I.M. group
|
Procedure: intramedullary tibial Nailing
Fractures well be fixed using intramedullary nails
Other Name: Expert Tibial Nail ®
|
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 ®
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047826
Contacts
| Contact: Husam A AL-Rumaih, MD | +96612520088 ext 14119 | rumaih@me.com |
| Contact: Wael S Taha, MD | +96612520088 ext 14117 | waelstaha@gmail.com |
Locations
| Saudi Arabia | |
| King Abdullah International Medical Research Center | Recruiting |
| Riyadh, Central, Saudi Arabia, 11426 | |
| Contact: Husam A AL-Rumaih, MD +96612520088 ext 14119 rumaih@me.com | |
| Contact: Sami I AL-Essia, MD +96612520088 ext 14119 saleissa@yahoo.com | |
| Principal Investigator: Wael S Taha, MD | |
| Sub-Investigator: Abdulaziz AL-Ammari, MD | |
Sponsors and Collaborators
King Abdullah International Medical Research Center
Investigators
| Principal Investigator: | Husam A AL-Rumaih, MD | National Guard Heath Affaires, Saudi Arabia |
| Study Director: | Wael S Taha, MD | National Guard Health Affairs |
| Study Chair: | Sami I AL-Essia, MD | National Guard Health Affairs |
More Information
Additional Information:
No publications provided
| Responsible Party: | Husam A. AL-Rumaih/Dr, King Abdullah International Medical Research Center |
| ClinicalTrials.gov Identifier: | NCT01047826 History of Changes |
| Other Study ID Numbers: | RC09/128 |
| Study First Received: | January 12, 2010 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Saudi Arabia: Research Advisory Council |
Keywords provided by King Abdullah International Medical Research Center:
|
Fractured Tibia Expert Tibial Nail Minimally Invasive Plate Osteosynthesis (M.I.P.O) Intramedullary Nailing |
Locked Plate distal third 43-A |
Additional relevant MeSH terms:
|
Fractures, Bone Tibial Fractures Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on June 13, 2013