Press-Fit vs Loose-Fit Implants for Broken Elbow
(PROFIT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study compares two types of artificial implants used to replace a broken part of the elbow (the radial head) when the bone is too damaged to repair. One implant (press-fit) is designed to grip the bone tightly so bone grows into it and holds it in place. The other implant (loose-fit) has a smooth stem that sits loosely in the bone and is meant to move slightly. Both implants are already approved and widely used; doctors do not yet know if one works better than the other. People taking part are placed by chance into one of the two implant groups. The study will follow them for at least 2 years to see how far they can bend and straighten the elbow, how much pain they have, how well the elbow works in daily life, whether the implant stays in good position on X-rays, and whether any further surgery is needed.
Who Is on the Research Team?
Amir Kachooei, MD PhD
Principal Investigator
Rothman Orthopedics at AdventHealth
Are You a Good Fit for This Trial?
This trial is for adults with a broken or badly damaged radial head (part of the elbow) that can't be fixed and needs to be replaced. People with certain other health issues, like severe liver disease, may not qualify.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Skeletal Dynamics Radial Head (Press-Fit)
- Stryker Radial Head (Loose-Fit)
Trial Overview
The study compares two types of artificial elbow implants: one that fits tightly into the bone (press-fit) and another that sits more loosely (loose-fit). Participants are randomly assigned to receive one type and followed for at least 2 years.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients undergoing primary RHA with a press-fit (grit-blasted or porous-coated, ingrowth-dependent) radial head implant - Skeletal Dynamics radial head prosthesis.
Patients undergoing primary RHA with a loose-fit (smooth-stem spacer) radial head implant - Stryker radial head prosthesis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AdventHealth
Lead Sponsor
Hospital Universitario La Paz
Collaborator
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