Two ways to fix distal femur fractures in older adults
Official title: Single Impact Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures in Geriatric Patients
Run by Wake Forest University Health Sciences · NCT07237191 · Data updated 2026-11-12
This trial tests whether a single implant or two implants help older adults with distal femur fractures return to work and daily activities sooner.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 256 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Charlotte, North Carolina) |
| Status | Recruiting |
| Started | August 23, 2026 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07237191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 55 years or older with surgically treated displaced distal femur fractures (extra-articular or complete articular).
✕Probably not a fit
Patients unlikely to benefit are those with factors precluding fixation with two implants, poor follow-up likelihood, BMI over 40, or other injuries interfering with recovery.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares single-implant fixation to dual-implant fixation for displaced distal femur fractures in adults aged 55 and older. It aims to determine which surgical approach yields faster recovery and betterearly return to daily activities. The study addresses the high nonunion rate in distal femur fractures and seeks to see if fixation strategy can improve healing and function. Participants are adults with surgically treated displaced distal femur fractures, consenting to follow-up evaluations. The trial is conducted at Atrium Health in Charlotte, NC, sponsored by Wake Forest University Health Sciences.
Why it matters
Potential benefit: If successful, the approach that leads to faster healing and quicker return to work and daily activities could improve quality of life for older adults with distal femur fractures.
How similar studies have gone: Prior work has explored various fixation strategies but nonunion remains a challenge; this study tests a potentially beneficial comparison in a real-world setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Atrium Health
Charlotte, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Laurence Kempton, M.D. — Wake Forest University Health Sciences
- Study coordinator: Laurence Kempton, M.D.
- Email: laurence.kempton@advocatehealth.org
- Phone: 7042553035
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing single and dual implant methods for fixing distal femur fractures
This study is testing whether using one or two implants to fix certain types of thigh bone fractures helps patients heal better and get back to their daily activities faster.
-
Smart Crutch Tips to guide weight-bearing after extra-articular proximal tibia fracture surgery
This study will test whether personalized weight-bearing plans using Smart Crutch Tips help adults with extra-articular proximal tibia fractures heal faster, return to full weight-bearing sooner, and feel less fear of movement.
-
Comparing elbow hemiarthroplasty and ORIF for treating distal humeral fractures in older adults
This study is testing whether surgery to fix elbow fractures with plates and screws works better than replacing part of the elbow in older adults with these types of injuries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.