🔎 Trials Near Me

Home › Elbow Fractures › NCT07932704

Press-Fit vs Loose-Fit Radial Head Arthroplasty

Recruiting

Outcomes of Press-Fit vs Loose-Fit Radial Head Implants: A Prospective Single-Blinded Randomized Control Trial With a Minimum Follow-Up of 2 Years

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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 significant comorbidities that could interfere with rehabilitation or study participation, including but not limited to:

   * Severe osteoarthritis affecting elbow function
   * Rheumatoid arthritis or other autoimmune disorders affecting musculoskeletal function
   * Full-thickness cartilage lesion in the elbow joint
   * Neurological or vascular complications
   * Neuromuscular disorders affecting movement or coordination
   * Neurocognitive conditions impacting study participation
   * Chronic infections or immunodeficiency conditions
   * Uncontrolled diabetes
   * Cardiovascular diseases (e.g., congestive heart failure, ischemic heart disease)
   * Severe chronic obstructive pulmonary disease (COPD) or other significant respiratory conditions
   * Renal insufficiency or chronic kidney disease (stage 3 or higher)
   * Obesity with a body mass index (BMI) \> 40
   * Active cancer treatment or history of cancer within the past 5 years
2. Known allergy or contraindication to any surgical materials used in the radial head implant procedure.
3. Patients currently participating in another clinical trial that may interfere with this study's outcomes.
4. Risk factors for poor implant integration and healing, including:

   * Active alcohol or substance dependence
   * Nicotine/tobacco use
   * Chronic corticosteroid use
   * Recent chemotherapy
5. Any condition that, in the opinion of the principal investigator, would make participation in the study unsafe or not in the patient's best interest.

About the study

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.

What is being tested

Sponsor: AdventHealth · Participants: 130 · Started: Jan 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07932704

Locations in the U.S.

FloridaAdventHealth, Orlando

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.