Recruiting

Press-Fit vs. Loose-Fit

Sponsor:

AdventHealth

Code:

NCT07932704

Conditions

Radial Head Fractures

Elbow Fractures

Elbow Dislocation

Elbow Injuries and Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Skeletal Dynamics Radial Head (Press-Fit)

Stryker Radial Head (Loose-Fit).

Study Details

Brief summary:

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.

Conditions

Radial Head Fractures

Elbow Fractures

Elbow Dislocation

Elbow Injuries and Disorders

Study ID

NCT07932704

Start date

Jan 16, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Sep, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Press-Fit Radial Head Arthroplasty

Patients undergoing primary RHA with a press-fit (grit-blasted or porous-coated, ingrowth-dependent) radial head implant - Skeletal Dynamics radial head prosthesis.

active comparator: Loose-Fit Radial Head Arthroplasty

Patients undergoing primary RHA with a loose-fit (smooth-stem spacer) radial head implant - Stryker radial head prosthesis.

Interventions

Skeletal Dynamics Radial Head (Press-Fit)

Skeletal Dynamics Radial Head (Press-Fit). Surgical placement of a press-fit radial head prosthesis sized for interference fit within the radial canal.

Stryker Radial Head (Loose-Fit).

Surgical placement of a smooth-stem radial head prosthesis functioning as a spacer permitting rotation and micromotion.

Primary outcome measure

  • Elbow Flexion-Extension Arc of Motion [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperatively ]

Central Contacts and Locations

Locations

AdventHealth

Recruiting

Orlando, Florida, United States, 32827

Contacts

Amir Kachooei, MD PhD

(844) 407-4070amir.kachooei@rothmanortho.com

More Information

Sponsor

AdventHealth

Last update posted

Nov 12, 2026

Last verified

Aug, 2026

Keywords

  • radial head arthroplasty
  • Press-Fit Implant
  • Loose-Fit Implant
  • Elbow
  • Radial Head Prosthesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by AdventHealth on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.