Pulmonary ComplicationsNCT01042132
Intramedullary Femoral Reaming, Human Study
A study testing the effect of delayed intramedullary reaming and the reaming of the femoral canal is performed with two different reaming devices in people with Pulmonary Complications and Organ Failure, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Complications, Organ Failure, Systemic Inflammatory Response Syndrome
- What is being tested?
- the effect of delayed intramedullary reaming and the reaming of the femoral canal is performed with two different reaming devices
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- May 2003to May 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- femoral shaft fracture suitable for intramedullary nailing
- < 24 hours postinjury
Who cannot join
- previous fracture of the femur
- pathological fracture
- femur deformities
- pregnancy
- previous intramedullary nailing or external fixation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture
To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).
Read the detailed description
To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).
- Being tested
- the effect of delayed intramedullary reaming, the reaming of the femoral canal is performed with two different reaming devices
- Keywords
- intramedullary reaming, inflammatory response, human, femoral shaft fracture, Reamer-irrigator-aspirator
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the effect of delayed intramedullary reamingProcedure or surgery
in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.
the reaming of the femoral canal is performed with two different reaming devicesProcedure or surgery
the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)
| Study group | Role | What they receive |
|---|---|---|
| 1) IMN and EF/IMN | Active comparator | Two parts of the study are randomized;
1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing Receives: Procedure: the effect of delayed intramedullary reaming |
| 2) TR and RIA | Active comparator | Two parts of the study are randomized; 2)traditional reaming (TR)is compared to a new reaming device, RIA, which is a reamer connected to suction and flushing for prevention of increased intramedullary pressure Receives: Procedure: the reaming of the femoral canal is performed with two different reaming devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiopulmonary alterations
Measured: the first three postoperative days
coagulation, fibrinolytic and cytokine response
Measured: pre-, per- and first 3 days postoperatively
Secondary outcomes (1)
fracture healing
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 posted5 Jan 2010 (estimated)
- Study startMay 2003
- Primary completionOct 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Ellingsen Husebye, Oslo University Hospital
- Investigators
- Olav Røise, MD, Study director, Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042132
- Sponsor's protocol ID
- 02066
- Status last verified
- Apr 2002
- First submitted
- 4 Jan 2010
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture
- ClinicalTrials.gov ID
- NCT01042132
- Acronym / sponsor ID
- 02066
- Keywords
- intramedullary reaming, inflammatory response, human, femoral shaft fracture, Reamer-irrigator-aspirator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 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.
To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).
Detailed description
To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) IMN and EF/IMN | Active comparator | Procedure: the effect of delayed intramedullary reamingTwo parts of the study are randomized; 1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing |
| 2) TR and RIA | Active comparator | Procedure: the reaming of the femoral canal is performed with two different reaming devicesTwo parts of the study are randomized; 2)traditional reaming (TR)is compared to a new reaming device, RIA, which is a reamer connected to suction and flushing for prevention of increased intramedullary pressure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- femoral shaft fracture suitable for intramedullary nailing
- < 24 hours postinjury
Key exclusion criteria (5 listed)
- previous fracture of the femur
- pathological fracture
- femur deformities
- pregnancy
- previous intramedullary nailing or external fixation
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 |
|---|---|---|
| the effect of delayed intramedullary reamingin one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed. | Procedure or surgery | 1) IMN and EF/IMN |
| the reaming of the femoral canal is performed with two different reaming devicesthe reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA) | Procedure or surgery | 2) TR and RIA |
Primary outcome
cardiopulmonary alterations
Time frame: the first three postoperative days
coagulation, fibrinolytic and cytokine response
Time frame: pre-, per- and first 3 days postoperatively
1 secondary outcome
fracture healing
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 1 Dec 2016.
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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.
Olav Røise, MD study director
Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the effect of delayed intramedullary reaming and the reaming of the femoral canal is performed with two different reaming devices in people with Pulmonary Complications and Organ Failure, run by Ullevaal University Hospital at 1 site in Norway.
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 1 Dec 2016. 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 Norway. 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?
cardiopulmonary alterations (time frame: the first three postoperative days). The study lists 2 primary outcomes in all. 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 1 Dec 2016; AzTrials last refreshed its copy on 31 Oct 2026.