AdventHealth
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.
Inclusion Criteria: 1. Age 18 years or older. 2. Scheduled for primary RHA. 3. Willing and able to provide written informed consent. 4. Willing and able to comply with post-operative follow-up visits at 3 months, 6 months, 1 year, and 2 years. 5. No concurrent elbow procedures such as ligament reconstruction or additional joint resurfacing at the time of RHA. 6. No prior history of revision RHA. 7. RHA to be performed using press-fit or loose-fit implants (no other fixation methods included). 8. Must be able to complete PROs independently. Exclusion Criteria: 1. Diagnosed with any significa…
Skeletal Dynamics Radial Head (Press-Fit). Surgical placement of a press-fit radial head prosthesis sized for interference fit within the radial canal.
Surgical placement of a smooth-stem radial head prosthesis functioning as a spacer permitting rotation and micromotion.
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