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

9 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

130

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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.
Aktiv komparator: Loose-Fit Radial Head Arthroplasty

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

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Elbow Flexion-Extension Arc of Motion
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Forearm Rotation Arc of Motion
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Through 24 months postoperatively

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

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

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AdventHealth

Samarbetspartners

Hospital Universitario La Paz

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 januari 2026

Primärt slutförande (Beräknad)

1 september 2031

Avslutad studie (Beräknad)

1 september 2031

Studieregistreringsdatum

Först inskickad

29 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

9 november 2026

Första postat (Faktisk)

12 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2292000

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

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