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Infrapatellar vs Suprapatellar Approach for Tibial Fracture (INSURT Trial)

N/A
Waitlist Available
Led By Darius G Viskontas, 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
All extra-articular tibial fractures
Simple distal tibial intra-articular fractures amenable to IMN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 6,12 and 24 months post treatment
Awards & highlights

INSURT Trial Summary

This trial will compare two ways of attaching a metal rod to the shinbone to treat a broken shinbone. One way goes through the kneecap and the other goes around it.

Eligible Conditions
  • Tibial Fracture
  • Patellofemoral Pain Syndrome

INSURT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have fractures in the lower leg bone that are not located around the joints.
Select...
You have a specific type of fracture in your lower leg that can be treated with a specific type of surgery called IMN (Intramedullary Nail).
Select...
You have a broken bone that is either visible or not visible on the surface of your skin.
Select...
You have fractures in both of your shin bones.

INSURT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 6,12 and 24 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 6,12 and 24 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee
Secondary outcome measures
Distributions, Clinical
AST (Aberdeen Standing Weight-Distribution Test)
EQ-5D Health Related Quality of Life Outcome Measure
+5 more

INSURT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Semi-extended suprapatellar approachExperimental Treatment1 Intervention
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve).
Group II: Infrapatellar approachActive Control1 Intervention
Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suprapatellar Approach
2016
N/A
~250

Find a Location

Who is running the clinical trial?

Fraser Orthopaedic Research SocietyLead Sponsor
8 Previous Clinical Trials
596 Total Patients Enrolled
Darius G Viskontas, MD, FRCSCPrincipal InvestigatorRoyal Columbian Hospital / Fraser Health Authority
1 Previous Clinical Trials
80 Total Patients Enrolled
Trevor B Stone, MD, FRCSCPrincipal InvestigatorRoyal Columbian Hospital / Fraser Health Authority

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants to join this trial?

"Clinicaltrials.gov reveals that this medical trial, which first appeared on September 13th 2016, is not presently recruiting; however, there are 372 other trials currently enrolling patients."

Answered by AI

What criteria must potential participants meet in order to join this clinical trial?

"This trial is in search of 248 volunteers aged 18 to 65 who have experienced a segond fracture. Additionally, all recruits must be presenting with extra-articular tibial fractures (open or closed), agree to abide by the study protocol, and participate in follow-up visits; furthermore, they must demonstrate their capacity for consent."

Answered by AI

Does this clinical trial have any age restrictions, in particular for individuals over fifty?

"This trial has an age cap of 65 years old and a minimum enrollment age of 18."

Answered by AI

How many medical facilities are participating in this investigation?

"Presently, this medical trial is conducted in 5 different locations including Ottawa, Edmonton and New Westminster. It would be prudent to find the nearest clinic if you plan on participating in order to abridge travelling requirements."

Answered by AI
Recent research and studies
~29 spots leftby Mar 2025