Tibia FractureMINTNCT01047826
M.I.P.O. vs Intramedullary Nailing in Tibia Fractures
A study testing Minimally Invasive Plate Osteosynthesis and intramedullary tibial Nailing in people with Tibia Fracture, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tibia Fracture
- What is being tested?
- Minimally Invasive Plate Osteosynthesis and intramedullary tibial Nailing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Dec 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and Females aged from 18-60 years
- Closed Tibia Fracture
- Tibia Fracture Müller AO Class 43-A
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdullah International Medical Research Center
Riyadh, Central, 11426
Husam A AL-Rumaih, MD, +96612520088 ext. 14119, rumaih@me.com
Sami I AL-Essia, MD, +96612520088 ext. 14119, saleissa@yahoo.com
About this study
Official title: Intramedullary Nailing vs. M.I.P.O. in Fractures of the Tibia a Randomized Controlled Trial
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.
Read the 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 ®
- Conditions
- Tibia Fracture
- Being tested
- Minimally Invasive Plate Osteosynthesis, intramedullary tibial Nailing
- Keywords
- Fractured Tibia, Expert Tibial Nail, Minimally Invasive Plate Osteosynthesis (M.I.P.O), Intramedullary Nailing, Locked Plate, distal third, 43-A
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Plate OsteosynthesisProcedure or surgery
Also called Minimally invasive percutaneous plate osteosynthesis (MIPPO)
Fractures well be treated with locked plates using M.I.P.O. Technique
intramedullary tibial NailingProcedure or surgery
Also called Expert Tibial Nail ®
Fractures well be fixed using intramedullary nails
| Study group | Role | What they receive |
|---|---|---|
| M.I.P.O. Group | Experimental | subjects who have been randomized to the M.I.P.O. group Receives: Procedure: Minimally Invasive Plate Osteosynthesis |
| Intramedullary Nail group | Experimental | Subjects who have been Randomized to the I.M. group Receives: Procedure: intramedullary tibial Nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
The Short Form (12) Health Score (SF-12v2®)
Measured: every 3 months till healing or 24 months
Blood Loss
Measured: during the time of surgery
Radiation exposure
Measured: During the time of Surgery
Duration of Surgery
Measured: During the time of Surgery
Infection Rate
Measured: every 3 months till healing or 24 months
Hospital Stay
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibia FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Husam A AL-Rumaih, MD, Principal investigator, National Guard Heath Affaires, Saudi ArabiaWael S Taha, MD, Study director, National Guard Health AffairsSami I AL-Essia, MD, Study chair, National Guard Health Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047826
- Sponsor's protocol ID
- RC09/128
- Acronym
- MINT
- Status last verified
- Oct 2010
- First submitted
- 12 Jan 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Nailing vs. M.I.P.O. in Fractures of the Tibia a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01047826
- Acronym / sponsor ID
- MINT / RC09/128
- Conditions
- Tibia Fracture
- Keywords
- Fractured Tibia, Expert Tibial Nail, Minimally Invasive Plate Osteosynthesis (M.I.P.O), Intramedullary Nailing, Locked Plate, distal third, 43-A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 ®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M.I.P.O. Group | Experimental | Procedure: Minimally Invasive Plate Osteosynthesissubjects who have been randomized to the M.I.P.O. group |
| Intramedullary Nail group | Experimental | Procedure: intramedullary tibial NailingSubjects who have been Randomized to the I.M. group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and Females aged from 18-60 years
- Closed Tibia Fracture
- Tibia Fracture Müller AO Class 43-A
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Plate OsteosynthesisAlso: Minimally invasive percutaneous plate osteosynthesis (MIPPO)Fractures well be treated with locked plates using M.I.P.O. Technique | Procedure or surgery | M.I.P.O. Group |
| intramedullary tibial NailingAlso: Expert Tibial Nail ®Fractures well be fixed using intramedullary nails | Procedure or surgery | Intramedullary Nail group |
Primary outcome
Rate Of Malunion
Time frame: 6 months
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.
7 secondary outcomes
The Short Form (12) Health Score (SF-12v2®)
Time frame: every 3 months till healing or 24 months
Blood Loss
Time frame: during the time of surgery
Radiation exposure
Time frame: During the time of Surgery
Duration of Surgery
Time frame: During the time of Surgery
Infection Rate
Time frame: every 3 months till healing or 24 months
Hospital Stay
Time frame: After Surgery
Time Of Fracture Healing
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- The Trials webpageLink provided by the sponsor.
Related trials for Tibia Fracture
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Husam A AL-Rumaih, MD principal investigator
National Guard Heath Affaires, Saudi Arabia
Wael S Taha, MD study director
National Guard Health Affairs
Sami I AL-Essia, MD study chair
National Guard Health Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Plate Osteosynthesis and intramedullary tibial Nailing in people with Tibia Fracture, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Husam A AL-Rumaih, MD (+96612520088 ext. 14119, rumaih@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate Of Malunion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.