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Single vs Dual Implants for Broken Thigh Bones (PRORP Trial)

N/A
Waitlist Available
Led By Laurence Kempton, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 18 years
Surgically treated displaced distal femur extra articular or complete articular fractures
Must not have
Patient that speaks neither English or Spanish
Age less than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial aims to compare two types of surgeries for patients with certain types of thigh bone fractures. It wants to find out which surgery helps patients get back to work and daily activities faster.

Who is the study for?
This trial is for individuals with specific types of distal femur fractures (the bone just above the knee). It's not clear what the exact inclusion or exclusion criteria are, so it would be best to consult the study details or contact the research team directly.
What is being tested?
The trial compares two surgical methods: one using a single implant and another using dual implants to fix broken bones in the leg. The focus is on which method allows patients to return to work and daily life more effectively.
What are the potential side effects?
While side effects aren't listed, typical risks may include pain at surgery site, infection, blood clots, delayed bone healing, and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I had surgery for a severe knee fracture.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English or Spanish.
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I am under 18 years old.
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I was injured from a fall on the same level.
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My injury cannot be treated with two implants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Secondary study objectives
Change in Numeric Pain Rating
Change in Pain Inventory (BPI)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single Implant FixationExperimental Treatment1 Intervention
Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail.
Group II: Dual Implant FixationExperimental Treatment1 Intervention
Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,563 Total Patients Enrolled
United States Department of DefenseFED
891 Previous Clinical Trials
332,334 Total Patients Enrolled
Laurence Kempton, MDPrincipal InvestigatorWake Forest University Health Sciences
~96 spots leftby Dec 2026
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