Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
53 participants
OBSERVATIONAL
2021-02-01
2023-04-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
NCT05680987
Depuy Synthes Lower Extremity Shaft Nail Registry
NCT05272631
Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures
NCT05559736
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
NCT04015154
Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A
NCT04851509
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Historical patient data from other published studies in the literature
No interventions assigned to this group
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.
Depuy Synthes Advanced Retrograde femoral nail
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Depuy Synthes Advanced Retrograde femoral nail
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects who received the Depuy Synthes Advanced Retrograde Nail in accordance with the indications for use.
3. Subjects who have at least 6 months of follow-up.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DePuy Synthes
INDUSTRY
University of Alabama at Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Clay Spitler
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clay Spitler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-300008523
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.