Femoral FracturesNCT01548456
Nails Versus Plates for Femur Fractures in Dar es Salaam, Tanzania
An observational study of Femoral Fractures, run by University of California, San Francisco at 1 site in Tanzania.
Trial summary
This is a prospective observational study of patients with femur fractures in Dar es Salaam, Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open reduction internal fixation (ORIF) with a plate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Intramedullary Nailing and Open Reduction Internal Fixation
- Type of treatment
- Surgery or procedure
- How many people
- 332 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2012to Jul 2014
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with diaphyseal fractures of the femur presenting to Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania will be considered eligible for enrollment.
Who may be able to join
- Diaphyseal fracture amenable to operative fixation with an intramedullary nail or plate
- Age 18 to 65
Who cannot join
- Clinical evidence of infection at the surgical site (defined clinically as drainage or erythema)
- Pathologic fracture
- Prior surgery
- Presentation 3 weeks or more after injury
- Inability or unwillingness to comply with follow up to 1-year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intramedullary Nailing Versus Plates for Femoral Shaft Fractures in Dar es Salaam, Tanzania With Minimum 1-Year Follow-up
This is a prospective observational study of patients with femur fractures in Dar es Salaam, Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of reoperation for any reason, and the secondary outcomes are fracture healing, return to work, and health-related quality-of-life. The investigators hypothesize that there will be a difference in the rate of reoperation for patients with femur fractures treated with an IMN compared to ORIF with a plate.
Read the detailed description
The study will be a prospective clinical trial conducted at Muhimbili Orthopaedic Institute (MOI) in Dar es Salaam, Tanzania. All adult patients with diaphyseal femur fractures meeting the eligibility criteria will be invited to enroll. Study subjects will be treated at the discretion of the surgeons at MOI. This could include an intramedullary nail, a plate, external fixation, or skeletal traction. Potential confounders recorded will be age, gender, body mass index, comorbidities, fracture pattern, open versus closed injury, time from injury to presentation, time from presentation to surgery, and associated injuries. The primary outcome considered will be reoperation for any reason. Secondary outcomes will be clinical union, defined as full-painless weight bearing on the injured extremity, radiographic union, return to work, and health-related quality-of-life. Follow up will be scheduled at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery and will include both clinical and radiographic evaluation.
- Conditions
- Femoral Fractures
- Being tested
- Intramedullary Nailing, Open Reduction Internal Fixation
- Keywords
- femur fracture, internal fixation, intramedullary nailing
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary NailingProcedure or surgery
Also called SIGN Intramedullary Nail
Surgical treatment that includes closed or open reduction and stabilization of the femur fracture with an intramedullary rod inserted using antegrade or retrograde technique
Open Reduction Internal FixationProcedure or surgery
Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary nailing | Subjects with a femur fracture who undergo operative fixation with an intramedullary nail Receives: Procedure: Intramedullary Nailing | |
| Open Reduction Internal Fixation | Subjects with a femur fracture who undergo open reduction internal fixation with a dynamic compression plate Receives: Procedure: Open Reduction Internal Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Reoperation involving the affected femur for any reason within the first year will be considered an event.
Measured: 1-year
Secondary outcomes (4)
Health-related quality of life
Health-related quality of life as measured by the EQ-5D-3L (Swahili version) by the Euroqol Group
Measured: 1-year
Return to work
Time from surgery to return to work among patients employed at the time of injury
Measured: 1-year
Clinical union
Defined as full painless weight bearing on the affected extremity
Measured: 1-year
Radiographic Union
Bony healing as measured by the Radiographic Union Scale in Tibial Fractures (RUST) Score
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Research Foundation, Orthopaedic Trauma Association, Muhimbili Orthopaedic Institute
- Responsible party
- Sponsor
- Investigators
- David W Shearer, MD, MPH, Principal investigator, University of California, San FranciscoEdmund N Eliezer, MD, Study director, Muhimbili Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548456
- Sponsor's protocol ID
- UCSF 23346
- Status last verified
- May 2015
- First submitted
- 27 Feb 2012
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Nailing Versus Plates for Femoral Shaft Fractures in Dar es Salaam, Tanzania With Minimum 1-Year Follow-up
- ClinicalTrials.gov ID
- NCT01548456
- Acronym / sponsor ID
- UCSF 23346
- Conditions
- Femoral Fractures
- Keywords
- femur fracture, internal fixation, intramedullary nailing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Orthopaedic Research Foundation, Orthopaedic Trauma Association, Muhimbili Orthopaedic Institute
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Mar 2012 (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.
This is a prospective observational study of patients with femur fractures in Dar es Salaam, Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of reoperation for any reason, and the secondary outcomes are fracture healing, return to work, and health-related quality-of-life. The investigators hypothesize that there will be a difference in the rate of reoperation for patients with femur fractures treated with an IMN compared to ORIF with a plate.
Detailed description
The study will be a prospective clinical trial conducted at Muhimbili Orthopaedic Institute (MOI) in Dar es Salaam, Tanzania. All adult patients with diaphyseal femur fractures meeting the eligibility criteria will be invited to enroll. Study subjects will be treated at the discretion of the surgeons at MOI. This could include an intramedullary nail, a plate, external fixation, or skeletal traction. Potential confounders recorded will be age, gender, body mass index, comorbidities, fracture pattern, open versus closed injury, time from injury to presentation, time from presentation to surgery, and associated injuries. The primary outcome considered will be reoperation for any reason. Secondary outcomes will be clinical union, defined as full-painless weight bearing on the injured extremity, radiographic union, return to work, and health-related quality-of-life. Follow up will be scheduled at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery and will include both clinical and radiographic evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramedullary nailing | – | Procedure: Intramedullary NailingSubjects with a femur fracture who undergo operative fixation with an intramedullary nail |
| Open Reduction Internal Fixation | – | Procedure: Open Reduction Internal FixationSubjects with a femur fracture who undergo open reduction internal fixation with a dynamic compression plate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with diaphyseal fractures of the femur presenting to Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania will be considered eligible for enrollment.
Key inclusion criteria (2 listed)
- Diaphyseal fracture amenable to operative fixation with an intramedullary nail or plate
- Age 18 to 65
Key exclusion criteria (5 listed)
- Clinical evidence of infection at the surgical site (defined clinically as drainage or erythema)
- Pathologic fracture
- Prior surgery
- Presentation 3 weeks or more after injury
- Inability or unwillingness to comply with follow up to 1-year
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 |
|---|---|---|
| Intramedullary NailingAlso: SIGN Intramedullary NailSurgical treatment that includes closed or open reduction and stabilization of the femur fracture with an intramedullary rod inserted using antegrade or retrograde technique | Procedure or surgery | Intramedullary nailing |
| Open Reduction Internal FixationSurgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate | Procedure or surgery | Open Reduction Internal Fixation |
Primary outcome
Reoperation
Time frame: 1-year
Reoperation involving the affected femur for any reason within the first year will be considered an event.
4 secondary outcomes
Health-related quality of life
Time frame: 1-year
Return to work
Time frame: 1-year
Clinical union
Time frame: 1-year
Radiographic Union
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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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.
David W Shearer, MD, MPH principal investigator
University of California, San Francisco
Edmund N Eliezer, MD study director
Muhimbili Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fractures, run by University of California, San Francisco at 1 site in Tanzania.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 19 May 2015. 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 Tanzania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation (time frame: 1-year). 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 19 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.