An interventional study of PFN-A in Unstable Proximal Femoral Fracture, sponsored by Ferran Fillat Gomà. Completed at 1 site in Spain. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2017-02-02.
Sponsored by Ferran Fillat Gomà · Not applicable, Interventional, and Treatment
Introduction:
Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial is performed to compare the outcome treatment of these unstable fractures of the proximal part of the femur with either a short PFN-A (170-240mm) or long PFN-A (300-420mm).
Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer complications than Long PFN-A
Main Objective: Is defined as Total number of complications between PFN-A short and PFN-A long. Outcome measures were subdivided into preoperative, perioperative and post-operative. Follow up data at four weeks, three months and one year.
Secondary objectives: Complete and uneventful radiological and clinical healing of the fracture. Revision operations (related to the failure of primary treatment) and mortality. Baseline characteristics were documented pre-operatively: Outcome measures were subdivided into intra-operative, post-operative and follow up data at four weeks, three months and one year.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 188 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →This is the only study on the registry with Ferran Fillat Gomà as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm)
Device: PFN-A
Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm)
Device: PFN-A
Also known as: Proximal femoral nail Synthes
Total number of complications between PFN-A short and PFN-A long
follow-up data is recruited at 4 weeks, 3 months and one
Time frame: One year
Complete and uneventful radiological and clinical healing of the fracture and mortality
follow-up data is recruited at 4 weeks, 3 months and one year.
Time frame: One year
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.