Recruiting

Surgical Fixation Comparison

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07237191

Conditions

Articular Fractures

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Single Implant Fixation

Dual Implant Fixation

Study Details

Brief summary:

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.

Conditions

Articular Fractures

Study ID

NCT07237191

Start date

Aug 23, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age greater than or equal to 55 years
  • Surgically treated displaced distal femur extra articular or complete articular fractures

Exclusion Criteria:

  • Patients with injury features that preclude treatment with 2 implants
  • Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
  • Body Mass Index (BMI) > 40
  • Injury due to ground level fall
  • Patient that speaks neither English or Spanish
  • Patients with multisystem injuries that could preclude return to work
  • < 55 years of age
  • Prisoner

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Single Implant Fixation

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

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.

Primary outcome measure

  • Number of Unions [ Time Frame: 6-week, 3, 6, 12 months ]
  • Total Surgical Time - Reoperations [ Time Frame: 6-week, 3, 6, 12 months ]
  • Number of Reoperations [ Time Frame: 6-week, 3, 6, 12 months ]

Central Contacts and Locations

Central contacts

Laurence Kempton, M.D.

7042553035laurence.kempton@advocatehealth.org

Locations

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28204

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • distal femur fractures
  • single implant fixation
  • dual implant fixation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.