Femur FractureRFNANCT05668117
RFN-Advanced Retrograde Femoral Nailing System
An observational study of Femur Fracture, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is a retrospective chart review of the safety and performance Standard of Care data on individuals that have previously been implanted with the femur nail of the RFNA System for the internal fixation of the femur. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Depuy Synthes Advanced Retrograde femoral nail
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 27 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with non-pathologic distal femur and femoral shaft fractures treated with the Depuy Synthes Advanced Retrograde femoral nail.
Who may be able to join
- Subjects 18 years or older at the time of index procedure
- Subjects who received the Depuy Synthes Advanced Retrograde Nail in accordance with the indications for use.
- Subjects who have at least 6 months of follow-up.
Who cannot join
- Subject with less than 6 months of follow up, pathologic fractures, and patients < 18 years of age will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35223
About this study
Official title: RFN-Advanced Retrograde Femoral Nailing System (RFNA) - Early Usage Case-Series Utilizing the Retrograde Femoral Nail-Advanced for Fixation and Stabilization of the Distal Femur and Femoral Shaft
This study is a retrospective chart review of the safety and performance Standard of Care data on individuals that have previously been implanted with the femur nail of the RFNA System for the internal fixation of the femur. Demographics, medical history, primary diagnosis, mechanism of injury, type of injury, clinical and radiographic evaluation of bone consolidation, and device-related adverse events were collected. Descriptive statistics were applied to the data collected.
- Conditions
- Femur Fracture
- Being tested
- Depuy Synthes Advanced Retrograde femoral nail
- Keywords
- Intramedullary Nail, Retrograde, Union
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depuy Synthes Advanced Retrograde femoral nailDevice
The Advanced Retrograde Femoral Nailing System (RFNA) is designed to improve fixation and stabilization of distal femur and femoral shaft fractures by reducing toggle and loss of reduction.
| Study group | Role | What they receive |
|---|---|---|
| Control | Historical patient data from other published studies in the literature | |
| Study participants | Adult patients with non-pathologic distal femur and femoral shaft fractures treated with the Depuy Synthes Advanced Retrograde femoral nail who had at least 6 months of follow up. Receives: Device: Depuy Synthes Advanced Retrograde femoral nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union
Rate of fracture union
Measured: 6 months
Secondary outcomes (4)
Infection
Rate of infection
Measured: 6 months
Implant breakage
Rate of implant breakage
Measured: 6 months
Implant removal
Rate of symptomatic implant removal
Measured: 6 months
Malunion
Rate of malunion
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 posted29 Dec 2022
- Study start1 Feb 2021
- Primary completion31 Jul 2022
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Principal investigator, Clay Spitler, University of Alabama at Birmingham
- Investigators
- Clay Spitler, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668117
- Sponsor's protocol ID
- IRB-300008523
- Acronym
- RFNA
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2022
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
PubMed 16814787Ehlinger M, Ducrot G, Adam P, Bonnomet F. Distal femur fractures. Surgical techniques and a review of the literature. Orthop Traumatol Surg Res. 2013 May;99(3):353-60. doi: 10.1016/j.otsr.2012.10.014. Epub 2013 Mar 18.
PubMed 23518071Ricci WM, Gallagher B, Haidukewych GJ. Intramedullary nailing of femoral shaft fractures: current concepts. J Am Acad Orthop Surg. 2009 May;17(5):296-305. doi: 10.5435/00124635-200905000-00004.
PubMed 19411641Iannacone WM, Bennett FS, DeLong WG Jr, Born CT, Dalsey RM. Initial experience with the treatment of supracondylar femoral fractures using the supracondylar intramedullary nail: a preliminary report. J Orthop Trauma. 1994 Aug;8(4):322-7. doi: 10.1097/00005131-199408000-00008.
PubMed 7965294Ricci WM, Bellabarba C, Lewis R, Evanoff B, Herscovici D, Dipasquale T, Sanders R. Angular malalignment after intramedullary nailing of femoral shaft fractures. J Orthop Trauma. 2001 Feb;15(2):90-5. doi: 10.1097/00005131-200102000-00003.
PubMed 11232660Tucker MC, Schwappach JR, Leighton RK, Coupe K, Ricci WM. Results of femoral intramedullary nailing in patients who are obese versus those who are not obese: a prospective multicenter comparison study. J Orthop Trauma. 2007 Sep;21(8):523-9. doi: 10.1097/BOT.0b013e31813347ac.
PubMed 17805018Gregory P, DiCicco J, Karpik K, DiPasquale T, Herscovici D, Sanders R. Ipsilateral fractures of the femur and tibia: treatment with retrograde femoral nailing and unreamed tibial nailing. J Orthop Trauma. 1996;10(5):309-16. doi: 10.1097/00005131-199607000-00004.
PubMed 8814571Moed BR, Watson JT. Retrograde nailing of the femoral shaft. J Am Acad Orthop Surg. 1999 Jul-Aug;7(4):209-16. doi: 10.5435/00124635-199907000-00001.
PubMed 10434075Oh CW, Oh JK, Park BC, Jeon IH, Kyung HS, Kim SY, Park IH, Sohn OJ, Min WK. Retrograde nailing with subsequent screw fixation for ipsilateral femoral shaft and neck fractures. Arch Orthop Trauma Surg. 2006 Sep;126(7):448-53. doi: 10.1007/s00402-006-0161-2. Epub 2006 Jun 21.
PubMed 16810555Shah S, Desai P, Mounasamy V. Retrograde nailing of femoral fractures: a retrospective study. Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1093-7. doi: 10.1007/s00590-015-1658-6. Epub 2015 Jul 1.
PubMed 26126587Jaarsma RL, Pakvis DF, Verdonschot N, Biert J, van Kampen A. Rotational malalignment after intramedullary nailing of femoral fractures. J Orthop Trauma. 2004 Aug;18(7):403-9. doi: 10.1097/00005131-200408000-00002.
PubMed 15289684El-Kawy S, Ansara S, Moftah A, Shalaby H, Varughese V. Retrograde femoral nailing in elderly patients with supracondylar fracture femur; is it the answer for a clinical problem? Int Orthop. 2007 Feb;31(1):83-6. doi: 10.1007/s00264-006-0137-4. Epub 2006 May 9.
PubMed 16683109Ricci WM, Bellabarba C, Evanoff B, Herscovici D, DiPasquale T, Sanders R. Retrograde versus antegrade nailing of femoral shaft fractures. J Orthop Trauma. 2001 Mar-Apr;15(3):161-9. doi: 10.1097/00005131-200103000-00003.
PubMed 11265005Singh SK, El-Gendy KA, Chikkamuniyappa C, Houshian S. The retrograde nail for distal femoral fractures in the elderly: high failure rate of the condyle screw and nut. Injury. 2006 Oct;37(10):1004-10. doi: 10.1016/j.injury.2006.01.005. Epub 2006 Feb 24.
PubMed 16499912
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RFN-Advanced Retrograde Femoral Nailing System (RFNA) - Early Usage Case-Series Utilizing the Retrograde Femoral Nail-Advanced for Fixation and Stabilization of the Distal Femur and Femoral Shaft
- ClinicalTrials.gov ID
- NCT05668117
- Acronym / sponsor ID
- RFNA / IRB-300008523
- Conditions
- Femur Fracture
- Keywords
- Intramedullary Nail, Retrograde, Union
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 29 Dec 2022 (actual)
- 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 study is a retrospective chart review of the safety and performance Standard of Care data on individuals that have previously been implanted with the femur nail of the RFNA System for the internal fixation of the femur. Demographics, medical history, primary diagnosis, mechanism of injury, type of injury, clinical and radiographic evaluation of bone consolidation, and device-related adverse events were collected. Descriptive statistics were applied to the data collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Historical patient data from other published studies in the literature |
| Study participants | – | Device: Depuy Synthes Advanced Retrograde femoral nailAdult patients with non-pathologic distal femur and femoral shaft fractures treated with the Depuy Synthes Advanced Retrograde femoral nail who had at least 6 months of follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with non-pathologic distal femur and femoral shaft fractures treated with the Depuy Synthes Advanced Retrograde femoral nail.
Key inclusion criteria (3 listed)
- Subjects 18 years or older at the time of index procedure
- Subjects who received the Depuy Synthes Advanced Retrograde Nail in accordance with the indications for use.
- Subjects who have at least 6 months of follow-up.
Key exclusion criteria (1 listed)
- Subject with less than 6 months of follow up, pathologic fractures, and patients < 18 years of age will be excluded from the study.
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 |
|---|---|---|
| Depuy Synthes Advanced Retrograde femoral nailThe Advanced Retrograde Femoral Nailing System (RFNA) is designed to improve fixation and stabilization of distal femur and femoral shaft fractures by reducing toggle and loss of reduction. | Device | Study participants |
Primary outcome
Union
Time frame: 6 months
Rate of fracture union
4 secondary outcomes
Infection
Time frame: 6 months
Implant breakage
Time frame: 6 months
Implant removal
Time frame: 6 months
Malunion
Time frame: 6 months
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 May 2023.
- Background: PubMed 16814787Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
- Background: PubMed 23518071Ehlinger M, Ducrot G, Adam P, Bonnomet F. Distal femur fractures. Surgical techniques and a review of the literature. Orthop Traumatol Surg Res. 2013 May;99(3):353-60. doi: 10.1016/j.otsr.2012.10.014. Epub 2013 Mar 18.
- Background: PubMed 19411641Ricci WM, Gallagher B, Haidukewych GJ. Intramedullary nailing of femoral shaft fractures: current concepts. J Am Acad Orthop Surg. 2009 May;17(5):296-305. doi: 10.5435/00124635-200905000-00004.
- Background: PubMed 7965294Iannacone WM, Bennett FS, DeLong WG Jr, Born CT, Dalsey RM. Initial experience with the treatment of supracondylar femoral fractures using the supracondylar intramedullary nail: a preliminary report. J Orthop Trauma. 1994 Aug;8(4):322-7. doi: 10.1097/00005131-199408000-00008.
- Background: PubMed 11232660Ricci WM, Bellabarba C, Lewis R, Evanoff B, Herscovici D, Dipasquale T, Sanders R. Angular malalignment after intramedullary nailing of femoral shaft fractures. J Orthop Trauma. 2001 Feb;15(2):90-5. doi: 10.1097/00005131-200102000-00003.
- Background: PubMed 17805018Tucker MC, Schwappach JR, Leighton RK, Coupe K, Ricci WM. Results of femoral intramedullary nailing in patients who are obese versus those who are not obese: a prospective multicenter comparison study. J Orthop Trauma. 2007 Sep;21(8):523-9. doi: 10.1097/BOT.0b013e31813347ac.
- Background: PubMed 8814571Gregory P, DiCicco J, Karpik K, DiPasquale T, Herscovici D, Sanders R. Ipsilateral fractures of the femur and tibia: treatment with retrograde femoral nailing and unreamed tibial nailing. J Orthop Trauma. 1996;10(5):309-16. doi: 10.1097/00005131-199607000-00004.
- Background: PubMed 10434075Moed BR, Watson JT. Retrograde nailing of the femoral shaft. J Am Acad Orthop Surg. 1999 Jul-Aug;7(4):209-16. doi: 10.5435/00124635-199907000-00001.
- Background: PubMed 16810555Oh CW, Oh JK, Park BC, Jeon IH, Kyung HS, Kim SY, Park IH, Sohn OJ, Min WK. Retrograde nailing with subsequent screw fixation for ipsilateral femoral shaft and neck fractures. Arch Orthop Trauma Surg. 2006 Sep;126(7):448-53. doi: 10.1007/s00402-006-0161-2. Epub 2006 Jun 21.
- Background: PubMed 26126587Shah S, Desai P, Mounasamy V. Retrograde nailing of femoral fractures: a retrospective study. Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1093-7. doi: 10.1007/s00590-015-1658-6. Epub 2015 Jul 1.
- Background: PubMed 15289684Jaarsma RL, Pakvis DF, Verdonschot N, Biert J, van Kampen A. Rotational malalignment after intramedullary nailing of femoral fractures. J Orthop Trauma. 2004 Aug;18(7):403-9. doi: 10.1097/00005131-200408000-00002.
- Background: PubMed 16683109El-Kawy S, Ansara S, Moftah A, Shalaby H, Varughese V. Retrograde femoral nailing in elderly patients with supracondylar fracture femur; is it the answer for a clinical problem? Int Orthop. 2007 Feb;31(1):83-6. doi: 10.1007/s00264-006-0137-4. Epub 2006 May 9.
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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.
Clay Spitler, MD principal investigator
University of Alabama at Birmingham
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 Femur Fracture, run by University of Alabama at Birmingham at 1 site 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 3 inclusion and 1 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 May 2023. 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 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?
Union (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668117, which also lists 14 linked publications.
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 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.