Depuy Synthes Lower Extremity Shaft Nail Registry

DePuy Synthes

Status: Active, not recruiting

Conditions: Tibial Fractures; Femoral Fractures

Treatments: Device: Tibial Nail Advanced; Device: Retrograde Femoral Nail Advanced

Study type: Observational

Funder types: Industry

Identifiers

NCT05272631

DST202103 (Other Identifier)

Details and patient eligibility

About

The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in participants who have experienced femoral or tibial fractures, respectively, requiring fixation and stabilization or who require a revision due to a malunion or a nonunion.

Enrollment: 250 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Skeletally mature adults age greater than or equal to (>=) 22 years (Retrograde Femoral Nail Advanced [RFNA], Tibial Nail Advanced [TNA]) and adolescents 12-21 years of age in which the growth plates have fused (TNA only)
• Participant receives an RFNA and/or TNA based on a diagnosis of open or closed, unilateral or bilateral femoral shaft or distal femur fracture (RFNA); unilateral or bilateral tibial fracture (TNA); revision of malunion or nonunion of previous fracture, or impending pathologic fracture (RFNA only) that will be treated operatively as part of standard of care. In addition, the following will be included: a) RFNA only: femoral shaft or distal femur fracture can be periprosthetic (PPFx) fracture after total or unicondylar knee arthroplasty, or total or hemi hip arthroplasty requiring nail osteosynthesis
• Participant (legally authorized representative if participant is a minor) voluntarily signs the Institutional Review Board (IRB)/ Ethics committee (EC) approved consent form
• Participant must be able to read and understand questions and responses in an available translated language for patient reported outcomes (PROs)

Exclusion criteria

• Participation in any other medical device or medicinal product study within the previous month. Participation in observational studies is allowed
• In the opinion of the Principal Investigator, participant is unable to comply with the requirements of the Registry
• Participant has known allergies to implant components

Trial design

250 participants in 2 patient groups

Retrograde Femoral Nail Advanced (RFNA) Cohort

Description:

Participants with a distal femur or femoral shaft fracture or who require revision due to a malunion or nonunion will undergo surgery with RFNA based on surgeon's decision and the site's standard of care (SOC). Participants with impending pathologic fracture are also included.

Treatment:

Device: Retrograde Femoral Nail Advanced

Tibial Nail Advanced (TNA) Cohort

Description:

Participants with open or closed, proximal, distal or shaft fractures of the tibia, or who require revision due to a malunion or nonunion will undergo surgery with TNA based on surgeon's decision and the site's SOC.

Treatment:

Device: Tibial Nail Advanced