Geriatric Distal Femur

Conditions

• Articular Fractures

Eligibility Criteria

Sex

ALL

Age

55 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Single Implant Fixation — PROCEDURE
  Lateral precontoured 4.5 mm distal femur plate or an intramedullary nail at the surgeon's discretion. Standard-of-care techniques will be used by the surgeon for fracture reduction and implant placement.
• Dual Implant Fixation — PROCEDURE
  Lateral precontoured distal femur plate and either (1) an intramedullary nail or (2) a medial plate. The medial plate must span the extra-articular portion of the fracture and must have stiffness of a 3.5 mm reconstruction plate, 3.5 mm limited contact dynamic compression plate, or greater.

Study Details

The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

Key Dates

First listed

Nov 19, 2025

Start date

Aug 23, 2026

Status verified

Oct 2025

Primary completion

Dec 31, 2028

Completion

Dec 31, 2029

Study Design

Enrollment

256 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Single Implant Fixation
  Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail which is the current standard of care.
• Other: Dual Implant Fixation
  Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate which is the current standard of care.

Primary Outcome Measure

Number of Unions [ Time Frame: 6-week, 3, 6, 12 months ]

Central Contacts

• Laurence Kempton, M.D.
  7042553035
  [email protected]

Locations (1)

Find similar trials in Charlotte, NC

Related Studies

• Single Versus Dual Implant Fixation of Distal Femur Fractures
  Recruiting · Wake Forest University Health Sciences · Birmingham, Alabama