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

9 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

130

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Dispositivo: 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.
Comparador activo: Loose-Fit Radial Head Arthroplasty

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

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Elbow Flexion-Extension Arc of Motion
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Forearm Rotation Arc of Motion
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Through 24 months postoperatively

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

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

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AdventHealth

Colaboradores

Hospital Universitario La Paz

Investigadores

  • Investigador principal: Amir Kachooei, MD PhD, Rothman Orthopedics at AdventHealth

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de enero de 2026

Finalización primaria (Estimado)

1 de septiembre de 2031

Finalización del estudio (Estimado)

1 de septiembre de 2031

Fechas de registro del estudio

Enviado por primera vez

29 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Publicado por primera vez (Actual)

12 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2292000

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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