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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT05668117
Study groupRoleWhat they receive
ControlHistorical patient data from other published studies in the literature
Study participantsAdult 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.

  1. Union

    Rate of fracture union

    Measured: 6 months

Secondary outcomes (4)

  1. Infection

    Rate of infection

    Measured: 6 months

  2. Implant breakage

    Rate of implant breakage

    Measured: 6 months

  3. Implant removal

    Rate of symptomatic implant removal

    Measured: 6 months

  4. 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.

  1. First posted29 Dec 2022
  2. Study start1 Feb 2021
  3. Primary completion31 Jul 2022
  4. Study completion27 Apr 2023

Resources

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)
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 16814787

  • Ehlinger 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 23518071

  • Ricci 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 19411641

  • Iannacone 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 7965294

  • Ricci 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 11232660

  • Tucker 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 17805018

  • Gregory 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 8814571

  • Moed 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 10434075

  • Oh 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 16810555

  • Shah 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 26126587

  • Jaarsma 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 15289684

  • El-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 16683109

  • Ricci 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 11265005

  • Singh 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

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.

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