Press-Fit vs Loose-Fit Radial Head Arthroplasty (PROFIT)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Madrid, Espagne
- Recrutement
- La Paz
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Contact:
- Raul Barco, MD PhD
- Numéro de téléphone: +34 917 27 70 00
- E-mail: atepac.hulp@salud.madrid.org
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Florida
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Orlando, Florida, États-Unis, 32827
- Recrutement
- AdventHealth
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Contact:
- Amir Kachooei, MD PhD
- Numéro de téléphone: (844) 407-4070
- E-mail: amir.kachooei@rothmanortho.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 18 years or older.
- Scheduled for primary RHA.
- Willing and able to provide written informed consent.
- Willing and able to comply with post-operative follow-up visits at 3 months, 6 months, 1 year, and 2 years.
- No concurrent elbow procedures such as ligament reconstruction or additional joint resurfacing at the time of RHA.
- No prior history of revision RHA.
- RHA to be performed using press-fit or loose-fit implants (no other fixation methods included).
- Must be able to complete PROs independently.
Exclusion Criteria:
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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
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Known allergy or contraindication to any surgical materials used in the radial head implant procedure.
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Patients currently participating in another clinical trial that may interfere with this study's outcomes.
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Risk factors for poor implant integration and healing, including:
- Active alcohol or substance dependence
- Nicotine/tobacco use
- Chronic corticosteroid use
- Recent chemotherapy
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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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Skeletal Dynamics Radial Head (Press-Fit). Surgical placement of a press-fit radial head prosthesis sized for interference fit within the radial canal. |
|
Comparateur actif: Loose-Fit Radial Head Arthroplasty
Patients undergoing primary RHA with a loose-fit (smooth-stem spacer) radial head implant - Stryker radial head prosthesis. |
Surgical placement of a smooth-stem radial head prosthesis functioning as a spacer permitting rotation and micromotion. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Elbow Flexion-Extension Arc of Motion
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Forearm Rotation Arc of Motion
Délai: 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
|
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Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Délai: Baseline (preoperative), 3, 6, 12, and 24 months postoperatively
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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)
Délai: Baseline (preoperative), 3, 6, 12, and 24 months postoperatively
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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
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Visual Analog Scale (VAS) for Pain
Délai: Baseline, 3, 6, 12, and 24 months postoperatively
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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
|
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Number of Participants Receiving Corticosteroid Injections
Délai: 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
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Number of Participants Requiring Reoperation
Délai: Through 24 months postoperatively
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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
|
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Number of Participants With Radiographic Implant Loosening
Délai: Through 24 months postoperatively
|
Intramedullary stem loosening on standard elbow radiographs. |
Through 24 months postoperatively
|
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Number of Participants With Radiographic Implant Subsidence
Délai: Through 24 months postoperatively
|
Implant subsidence on standard elbow radiographs compared with immediate postoperative radiographs. |
Through 24 months postoperatively
|
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Number of Participants With Radial Neck Resorption
Délai: Through 24 months postoperatively
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Radial neck bone resorption (stress shielding) on standard elbow radiographs. |
Through 24 months postoperatively
|
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Number of Participants With Heterotopic Ossification
Délai: Through 24 months postoperatively
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Heterotopic ossification on standard elbow radiographs. |
Through 24 months postoperatively
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Number of Participants With Surgical or Implant-Related Complications
Délai: Through 24 months postoperatively
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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
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Grip Strength
Délai: 3, 6, 12, and 24 months postoperatively
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Maximum grip strength of the operative hand in kilograms, measured with a hand-held dynamometer. |
3, 6, 12, and 24 months postoperatively
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Amir Kachooei, MD PhD, Rothman Orthopedics at AdventHealth
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2292000
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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