Femoral FracturesSTAFFNCT00534326
Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
A study testing Standard Reaming and Reaming/Irrigating/Aspirating in people with Femoral Fractures, run by Prisma Health-Upstate at 9 sites in United States.
Trial summary
Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Standard Reaming and Reaming/Irrigating/Aspirating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 9 sitesUnited States
- Study dates
- Dec 2006to 30 Dec 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between the ages of 18 years and 85 years;
- Acute fractures of the femoral shaft
Who cannot join
- Fractures not amenable to intramedullary nailing and deemed by the treating surgeon;
- Pathological fractures;
- Open fractures;
- Patients with additional injuries to the ipsilateral femur;
- Surgical delay of greater than 7 days from the time of injury;
- Retained hardware in the affected limb;
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- Previous infection in fractured limb;
- Likely problems in the judgment of the investigators with maintaining follow-up;
- Patients with severe cognitive injuries or disabilities will be excluded if it is deemed that they will be unable to complete the study questionnaires;
- Hopeless diagnosis;
- Medical comorbidities that prohibit the conductance of surgical treatment under a general anesthetic;
- Fractures requiring cephalomedullary nails
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Lahey Clinic
Burlington, Massachusetts, 01805
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Tennessee-Chattanooga Unit
Chattanooga, Tennessee, 37403
University of Missouri- Columbia
Columbia, Missouri, 65212
Palmetto Health
Columbia, South Carolina, 29203
Duke University Medical Center
Durham, North Carolina, 27710
Greenville Hospital System Univeristy Medical Center
Greenville, South Carolina, 29605
Indiana University
Indianapolis, Indiana, 46202
Carilion Medical Center
Roanoke, Virginia, 24033
About this study
Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based outcomes on these patients. Little information exists on the patient based outcomes following femur fractures. We hope that the patient based outcomes of this study will also be able to aid physicians in advising patients with femur fractures of their possible outcomes.
- Conditions
- Femoral Fractures
- Being tested
- Standard Reaming, Reaming/Irrigating/Aspirating
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ReamingProcedure or surgery
Femoral reaming using standard reaming techniques of multiple reamers
Reaming/Irrigating/AspiratingProcedure or surgery
Reaming using the Reamer/Irrigator/Aspirating
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard Reaming of femoral shaft fracture prior to intramedullary nailing Receives: Procedure: Standard Reaming |
| 2 | Active comparator | Reamer/Irrigator/Aspirating of femoral shaft fracture prior to intramedullary nailing Receives: Procedure: Reaming/Irrigating/Aspirating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture Healing
Measured: 3 months, 6 months, 1 year, 2 years
Secondary outcomes (1)
Patient Based Quality of Life
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2015
- Study completion30 Dec 2018
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri-Columbia
- Responsible party
- Sponsor
- Investigators
- Kyle J Jeray, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534326
- Sponsor's protocol ID
- Ort-07-06-06
- Acronym
- STAFF
- Status last verified
- Mar 2020
- First submitted
- 20 Sep 2007
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
- ClinicalTrials.gov ID
- NCT00534326
- Acronym / sponsor ID
- STAFF / Ort-07-06-06
- Conditions
- Femoral Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- University of Missouri-Columbia
- Study start
- Dec 2006
- Primary completion
- Dec 2015 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 24 Sep 2007 (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.
Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based outcomes on these patients. Little information exists on the patient based outcomes following femur fractures. We hope that the patient based outcomes of this study will also be able to aid physicians in advising patients with femur fractures of their possible outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Standard ReamingStandard Reaming of femoral shaft fracture prior to intramedullary nailing |
| 2 | Active comparator | Procedure: Reaming/Irrigating/AspiratingReamer/Irrigator/Aspirating of femoral shaft fracture prior to intramedullary nailing |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women between the ages of 18 years and 85 years;
- Acute fractures of the femoral shaft
Key exclusion criteria (12 listed)
- Fractures not amenable to intramedullary nailing and deemed by the treating surgeon;
- Pathological fractures;
- Open fractures;
- Patients with additional injuries to the ipsilateral femur;
- Surgical delay of greater than 7 days from the time of injury;
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 |
|---|---|---|
| Standard ReamingFemoral reaming using standard reaming techniques of multiple reamers | Procedure or surgery | 1 |
| Reaming/Irrigating/AspiratingReaming using the Reamer/Irrigator/Aspirating | Procedure or surgery | 2 |
Primary outcome
Fracture Healing
Time frame: 3 months, 6 months, 1 year, 2 years
1 secondary outcome
Patient Based Quality of Life
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
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 10 Mar 2020.
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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.
Kyle J Jeray, MD principal investigator
Prisma Health-Upstate
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Reaming and Reaming/Irrigating/Aspirating in people with Femoral Fractures, run by Prisma Health-Upstate at 9 sites in United States.
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 12 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
Fracture Healing (time frame: 3 months, 6 months, 1 year, 2 years). 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 10 Mar 2020.