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Procedure
Screw Locking Techniques for Hip Fracture (TFN-A Trial)
N/A
Recruiting
Led By Bertrand Perey, MD, FRCSC
Research Sponsored by Fraser Orthopaedic Research Society
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post treatment
Awards & highlights
TFN-A Trial Summary
This trial will compare the effects of two different types of locking on pertrochanteric fractures.
Who is the study for?
This trial is for adults over 18 with a specific type of hip fracture (AO/OTA 31-A) who were able to walk before their injury, even if they needed help. They must have a healthy other hip, be able to give consent, fill out questionnaires, and come to follow-up visits. People can't join if they're unlikely to follow up, have fractures around hip replacements or on both sides, non-healing bones, are bedridden or have dementia.Check my eligibility
What is being tested?
The study tests two ways of fixing broken hips using the TFN-Advanced nailing system: 'static locking' keeps the nail fixed in place while 'dynamic rotational locking' allows some movement. Patients will randomly get one method for two months before switching to the other; this cycle repeats until everyone's enrolled.See study design
What are the potential side effects?
While not specified here, surgical treatments like these may lead to pain at the surgery site, infection risk increase post-surgery, possible damage to surrounding muscles or nerves during operation and potential complications related to anesthesia.
TFN-A Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic Assessment
Secondary outcome measures
Complications
Femoral Offset
Fracture Reduction Quality
+1 moreTFN-A Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Static lockingExperimental Treatment1 Intervention
Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance of less than 25mm. The compression nut will be used to compress the fracture. The screw will then be statically locked using the 6Nm torque-limiting blue handle with 6mm hex coupling to completely lock the set screw down on the helical screw.
Group II: Dynamic rotational lockingActive Control1 Intervention
Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance less than 25mm. The compression nut will be used to compress the fracture. The screw will be rotationally locked by using the 5mm hex flexible screwdriver by advancing the set screw until it stops completely. The screw will then be turned counterclockwise by a ½ turn.
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Who is running the clinical trial?
DePuy SynthesIndustry Sponsor
30 Previous Clinical Trials
4,706 Total Patients Enrolled
Fraser Orthopaedic Research SocietyLead Sponsor
8 Previous Clinical Trials
626 Total Patients Enrolled
Bertrand Perey, MD, FRCSCPrincipal InvestigatorRoyal Columbian Hospital/Fraser Health Authority
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a hip fracture or hip replacement on the opposite side.I have a broken bone, whether the skin is broken or not.My fracture cannot be treated with a specific type of internal fixation.I cannot walk by myself.My fracture surgery was more than 14 days after the injury.I have fractures in both hips near the thigh bone.My broken bone hasn't healed properly.I have had fractures due to my disease.I have a spinal injury.I have other serious health issues that could shorten my life.I have a stable living situation and can attend all follow-up appointments.I am older than 18 years.My surgeon recommends a specific type of nail for my leg fracture.I was able to walk by myself or with help before my injury.My other hip is natural and has no fractures or implants.
Research Study Groups:
This trial has the following groups:- Group 1: Static locking
- Group 2: Dynamic rotational locking
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for participation in this trial at present?
"According to the clinicaltrials.gov registry, this study is at present enrolling patients; it was first listed on May 17th 2021 and modified as recently as July 26th 2022."
Answered by AI
What number of individuals are currently involved in this experiment?
"Affirmative. Clinicaltrials.gov verifies that this research initiative, which was first posted on May 17th 2021, is actively searching for participants. A total of 218 individuals need to be recruited from 1 location."
Answered by AI
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