An interventional study of Skeletal Dynamics Radial Head (Press-Fit) and Stryker Radial Head (Loose-Fit). in Radial Head Fractures, Elbow Fractures and Elbow Dislocation, sponsored by AdventHealth. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by AdventHealth · Not applicable, Interventional, and Treatment
Among 17 studies in Elbow Fractures with a site in United States — 7 open to participants now, 7 under way, none of them phase 3. Elbow Fractures · United States.
Among the 17 studies in Elbow Fractures with a site in United States, this one is the 4th largest by planned enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2026, is one of 10 with no phase, and was the 17th registered.
47 studies on the registry are indexed under Elbow Fractures; 13 are open to participants now.
Browse Elbow Fractures studies →7 of the 17 studies in Elbow Fractures with a site in United States are open now. Recruiting first, the newest first:
University of Oklahoma · Sites in United States
Ages 3–10 · Healthy volunteers
Nemours Children's Clinic · Sites in United States
Ages 3–18
Nemours Children's Clinic · Sites in United States
Ages up to 18 · Healthy volunteers
Joseph Janicki · Sites in United States
Ages 7–17
University of California, Los Angeles · Sites in United States
Ages 4–12
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Elbow Fractures studies recruiting now, 1 sets no upper age limit and 8 stop at 75 or younger; 8 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 130 is above the median of 60 across 29 interventional studies indexed under Elbow Fractures.
Median enrollment 85 across the 14 interventional studies, 61 across the 3 observational. Of the 9 that completed or were terminated, 4 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 17 have an industry lead sponsor. The 10 most frequent:
AdventHealth is the lead sponsor of 114 studies on the registry; 23 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
AdventHealth has 1 study filed under Elbow Fractures — fewer than ten, so there is no comparison to draw.
2 of the studies in Elbow Fractures with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07520851University of OklahomaEfficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal | 2027-04 |
| NCT07212036Nemours Children's ClinicThe Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures | 2027-09-01 |
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Among the 17 studies in Elbow Fractures with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnosed with any significant comorbidities that could interfere with rehabilitation or study participation, including but not limited to:
Risk factors for poor implant integration and healing, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing primary RHA with a press-fit (grit-blasted or porous-coated, ingrowth-dependent) radial head implant - Skeletal Dynamics radial head prosthesis.
Device: Skeletal Dynamics Radial Head (Press-Fit)
Patients undergoing primary RHA with a loose-fit (smooth-stem spacer) radial head implant - Stryker radial head prosthesis.
Device: Stryker Radial Head (Loose-Fit).
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.
Elbow Flexion-Extension Arc of Motion
Total arc of elbow flexion-extension in degrees (maximum flexion minus loss of extension), measured with a goniometer. The primary comparison between groups is at 24 months postoperatively. Measurements at earlier time points are reported to describe recovery over time.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperatively
Forearm Rotation Arc of Motion
Total arc of forearm rotation in degrees (maximum pronation plus maximum supination), measured with a goniometer.
Time frame: Baseline, 3, 6, 12, and 24 months postoperatively
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
The QuickDASH is an 11-item patient-reported questionnaire assessing upper extremity function and symptoms. Scores range from 0 to 100, and higher scores indicate greater disability (worse outcome).
Time frame: Baseline (preoperative), 3, 6, 12, and 24 months postoperatively
Mayo Elbow Performance Score (MEPS)
The MEPS assesses elbow pain, range of motion, stability, and ability to perform daily activities. Scores range from 0 to 100, and higher scores indicate better elbow function (better outcome).
Time frame: Baseline (preoperative), 3, 6, 12, and 24 months postoperatively
Visual Analog Scale (VAS) for Pain
Participants mark their pain intensity on a continuous line scored from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Time frame: Baseline, 3, 6, 12, and 24 months postoperatively
Number of Participants Receiving Corticosteroid Injections
Number of participants who receive one or more corticosteroid injections to the operative elbow after radial head arthroplasty.
Time frame: Through 24 months postoperatively
Number of Participants Requiring Reoperation
Number of participants who undergo any secondary surgical procedure on the operative elbow after the index radial head arthroplasty, including stiffness release and implant removal.
Time frame: Through 24 months postoperatively
Number of Participants With Radiographic Implant Loosening
Intramedullary stem loosening on standard elbow radiographs.
Time frame: Through 24 months postoperatively
Number of Participants With Radiographic Implant Subsidence
Implant subsidence on standard elbow radiographs compared with immediate postoperative radiographs.
Time frame: Through 24 months postoperatively
Number of Participants With Radial Neck Resorption
Radial neck bone resorption (stress shielding) on standard elbow radiographs.
Time frame: Through 24 months postoperatively
Number of Participants With Heterotopic Ossification
Heterotopic ossification on standard elbow radiographs.
Time frame: Through 24 months postoperatively
Number of Participants With Surgical or Implant-Related Complications
Number of participants with one or more complications related to the surgery or implant, including implant loosening, infection, stiffness, nerve injury, instability, or implant failure.
Time frame: Through 24 months postoperatively
Grip Strength
Maximum grip strength of the operative hand in kilograms, measured with a hand-held dynamometer.
Time frame: 3, 6, 12, and 24 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Sep 2031, 68 months after the start.
Of 15 interventional studies with no phase under Elbow Fractures, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 68 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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