BridgeMD
New treatment option for Distal Femur Fractures
Official title Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
ClinicalTrials.gov ID: NCT06944964
What this study is testing
- What it's testing
- The goal of this clinical trial is to assess the feasibility of conducting a larger study comparing single implant fixation (SIF) and dual implant fixation (DIF) for treating distal femur fractures (DFF) in older or compromised adults. It will also evaluate the safety and effectiveness of these treatments.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and Rorabeck type 1, 2) and either:
- Age ≥ 60 years or;
- Age 18-60 years with one or more of: i. Osteoporosis ii. Obesity (Body Mass Index \>30) iii. Metaphyseal comminution iv. Diabetes
- Fracture amenable to plating and nailing
- Ability to read and speak English or availability of a translator
You likely can't join if
- Candidate for primary or revision arthroplasty (surgeon opinion)
- Periprosthetic fracture with loose implant
- Gustillo grade III open fractures
- Ipsilateral hip implant
- Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)
- Non-ambulatory patients
See the full eligibility criteria
- Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and Rorabeck type 1, 2) and either:
- Age ≥ 60 years or;
- Age 18-60 years with one or more of: i. Osteoporosis ii. Obesity (Body Mass Index \>30) iii. Metaphyseal comminution iv. Diabetes
- Fracture amenable to plating and nailing
- Ability to read and speak English or availability of a translator
- Acute fractures (within 14-days of injury)
- No surgeon preference regarding SIF vs. DIF
- Provision of informed consent
- Candidate for primary or revision arthroplasty (surgeon opinion)
- Periprosthetic fracture with loose implant
- Gustillo grade III open fractures
- Ipsilateral hip implant
- Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)
- Non-ambulatory patients
- Multi-trauma patient (Injury Severity Score ≥ 16)
- Lack of bone substance or poor bone-quality which, in the surgeon's judgment, makes fixation impossible
- Any concomitant lower-extremity injury
- Inability to obtain informed consent due to language barrier
The study team makes the final eligibility decision.
Where it's taking place
- New Westminster, British Columbia, Canada
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Westminster, British Columbia, Canada; London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.