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.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Madrid, Hiszpania
- Rekrutacyjny
- La Paz
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Kontakt:
- Raul Barco, MD PhD
- Numer telefonu: +34 917 27 70 00
- E-mail: atepac.hulp@salud.madrid.org
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Florida
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Orlando, Florida, Stany Zjednoczone, 32827
- Rekrutacyjny
- AdventHealth
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Kontakt:
- Amir Kachooei, MD PhD
- Numer telefonu: (844) 407-4070
- E-mail: amir.kachooei@rothmanortho.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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. |
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Aktywny komparator: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Elbow Flexion-Extension Arc of Motion
Ramy czasowe: Baseline, 3 months, 6 months, 12 months, and 24 months postoperatively
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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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Forearm Rotation Arc of Motion
Ramy czasowe: Baseline, 3, 6, 12, and 24 months postoperatively
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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
Ramy czasowe: 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
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Mayo Elbow Performance Score (MEPS)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Through 24 months postoperatively
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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
Ramy czasowe: 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
Ramy czasowe: Through 24 months postoperatively
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Intramedullary stem loosening on standard elbow radiographs. |
Through 24 months postoperatively
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Number of Participants With Radiographic Implant Subsidence
Ramy czasowe: Through 24 months postoperatively
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Amir Kachooei, MD PhD, Rothman Orthopedics at AdventHealth
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2292000
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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