Extension Block Pinning vs Conservative Treatment for Mallet Finger Fractures (PO-EBPT)
Pin Orthosis Extension Block Pinning Versus Conservative Treatment for Doyle Type 4B Mallet Fractures
Mallet finger fractures are injuries affecting the tip of the finger and can be treated either with splinting or surgery. However, there is no clear agreement on which treatment provides better outcomes for certain types of these fractures.
In this study, patients with mallet finger fractures were randomly assigned to receive either surgical treatment using a pin-orthosis extension-block pinning technique or conservative treatment with splint immobilization. Patients were followed at regular intervals, and outcomes such as finger movement, function, bone healing, and complications were evaluated over time.
The purpose of this study is to compare these two treatment approaches and determine which one leads to better clinical and functional outcomes.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Mallet finger fractures, particularly those involving a significant portion of the distal interphalangeal joint articular surface, present a therapeutic challenge, and there is no consensus regarding the optimal treatment strategy. Both conservative management with splinting and various surgical techniques have been described in the literature.
This randomized controlled trial was designed to compare the clinical and radiographic outcomes of the pin-orthosis extension-block pinning technique and conventional conservative treatment in patients with mallet finger fractures. Patients were randomly assigned to either surgical or conservative treatment groups and followed at regular intervals.
Clinical and functional outcomes were assessed throughout the follow-up period to evaluate the effectiveness and safety of both treatment approaches."
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
Sultangazi
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Istanbul, Sultangazi, Tyrkia (Türkiye), 34265
- Haseki Training and Research Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age between 18 and 65 years
- Acute mallet fracture (≤ 3 weeks from injury)
- Fracture fragment involving 20-50% of the distal interphalangeal (DIP) joint articular surface
Exclusion Criteria:
- Open fractures
- Chronic mallet fractures (> 3 weeks from injury)
- Fracture fragment involving more than 50% of the DIP joint articular surface
- Open physes
- Inability to complete 12-month follow-up
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Surgical Treatment (PO-EBPT)
Participants in this group underwent surgical treatment using the pin-orthosis extension-block pinning technique.
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The pin-orthosis extension-block pinning technique was performed under appropriate anesthesia.
A Kirschner wire was used to block extension at the distal interphalangeal joint and stabilize the fracture fragment, followed by immobilization with an orthosis.
The fixation was maintained for a defined period, and patients were followed according to the study protocol.
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Aktiv komparator: Conservative Treatment (Splinting)
Participants in this group received conservative treatment with splint immobilization of the distal interphalangeal joint.
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Conservative treatment consisted of continuous splint immobilization of the distal interphalangeal joint in extension.
Patients were instructed to maintain uninterrupted splint use for the recommended duration with regular follow-up visits to monitor compliance and clinical progress.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Distal Interphalangeal Joint Extension Lag
Tidsramme: 12 months
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Degree of extension lag at the distal interphalangeal joint measured using a goniometer.
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Distal Interphalangeal Joint Range of Motion
Tidsramme: Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
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Range of motion of the distal interphalangeal joint measured in degrees.
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Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
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Functional Outcome According to Crawford Criteria
Tidsramme: 12 months
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Functional outcome assessed using the Crawford classification system.
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12 months
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Fracture Union
Tidsramme: Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
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Radiographic evidence of fracture healing assessed during follow-up.
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Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
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Complication Rate
Tidsramme: Up to 12 months
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Incidence of treatment-related complications observed during the study period.
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Up to 12 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Kemal A Col, Doctor, Haseki Training and Research Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 39-2022
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