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Press-Fit vs Loose-Fit Radial Head Arthroplasty (PROFIT)

9 november 2026 bijgewerkt door: AdventHealth

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

130

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Actieve vergelijker: Loose-Fit Radial Head Arthroplasty

Patients undergoing primary RHA with a loose-fit (smooth-stem spacer) radial head implant - Stryker radial head prosthesis.
Apparaat: Stryker Radial Head (Loose-Fit).

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Elbow Flexion-Extension Arc of Motion
Tijdsspanne: Baseline, 3 months, 6 months, 12 months, and 24 months postoperatively

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.
Baseline, 3 months, 6 months, 12 months, and 24 months postoperatively

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Forearm Rotation Arc of Motion
Tijdsspanne: Baseline, 3, 6, 12, and 24 months postoperatively

Total arc of forearm rotation in degrees (maximum pronation plus maximum supination), measured with a goniometer.
Baseline, 3, 6, 12, and 24 months postoperatively
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Tijdsspanne: Baseline (preoperative), 3, 6, 12, and 24 months postoperatively

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).
Baseline (preoperative), 3, 6, 12, and 24 months postoperatively
Mayo Elbow Performance Score (MEPS)
Tijdsspanne: Baseline (preoperative), 3, 6, 12, and 24 months postoperatively

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).
Baseline (preoperative), 3, 6, 12, and 24 months postoperatively
Visual Analog Scale (VAS) for Pain
Tijdsspanne: Baseline, 3, 6, 12, and 24 months postoperatively

Participants mark their pain intensity on a continuous line scored from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Baseline, 3, 6, 12, and 24 months postoperatively
Number of Participants Receiving Corticosteroid Injections
Tijdsspanne: Through 24 months postoperatively

Number of participants who receive one or more corticosteroid injections to the operative elbow after radial head arthroplasty.
Through 24 months postoperatively
Number of Participants Requiring Reoperation
Tijdsspanne: Through 24 months postoperatively

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.
Through 24 months postoperatively
Number of Participants With Radiographic Implant Loosening
Tijdsspanne: Through 24 months postoperatively

Intramedullary stem loosening on standard elbow radiographs.
Through 24 months postoperatively
Number of Participants With Radiographic Implant Subsidence
Tijdsspanne: Through 24 months postoperatively

Implant subsidence on standard elbow radiographs compared with immediate postoperative radiographs.
Through 24 months postoperatively
Number of Participants With Radial Neck Resorption
Tijdsspanne: Through 24 months postoperatively

Radial neck bone resorption (stress shielding) on standard elbow radiographs.
Through 24 months postoperatively
Number of Participants With Heterotopic Ossification
Tijdsspanne: Through 24 months postoperatively

Heterotopic ossification on standard elbow radiographs.
Through 24 months postoperatively
Number of Participants With Surgical or Implant-Related Complications
Tijdsspanne: Through 24 months postoperatively

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.
Through 24 months postoperatively
Grip Strength
Tijdsspanne: 3, 6, 12, and 24 months postoperatively

Maximum grip strength of the operative hand in kilograms, measured with a hand-held dynamometer.
3, 6, 12, and 24 months postoperatively

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AdventHealth

Medewerkers

Hospital Universitario La Paz

Onderzoekers

  • Hoofdonderzoeker: Amir Kachooei, MD PhD, Rothman Orthopedics at AdventHealth

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 januari 2026

Primaire voltooiing (Geschat)

1 september 2031

Studie voltooiing (Geschat)

1 september 2031

Studieregistratiedata

Eerst ingediend

29 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

9 november 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2292000

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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