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Open Reduction and Internal Fixation of Humeral Midshaft Fracture: Anterior Versus Posterior Plate Fixation

16. august 2026 oppdatert av: Dr Jahanzaib Ramay
About 13 out of 10,000 patients get a humeral shaft fracture each year, accounting for 1.0-3.0% of all fractures. The central part of the humerus is where 60% of all humeral fractures occur. A midshaft humerus fracture typically happens because of a direct impact to the upper arm. Trauma, such as falls, motor vehicle accidents, or motorcycle accidents, is the most common cause of fractures. Internally fixing humeral shaft fractures is often accomplished by a variety of surgical techniques. Usually, the posterior technique is used to repair distal and mid-shaft fractures. However, the posterior technique necessitates lateral or prone stance. The aim of this study comparing the outcomes of internal fixation and open reduction of humeral midshaft fractures utilizing anterior and posterior plate fixation. We want to conduct this study to get evidence to confirm whether which approach is more appropriate and more successful in such fractures. Moreover, the findings of this research could profoundly influence clinical outcomes by guiding orthopedic surgeons in their decision-making for management of humeral midshaft fracture.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Pakistan
    • Punjab Province
      • Sāhīwāl, Punjab Province, Pakistan, 57450
        • Rekruttering
        • Sahiwal Teaching Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Presenting with humeral midshaft fracture (presence of fracture in the middle part or center of humerus )

Exclusion Criteria:

  • Patients with pathological or open fractures, concomitant fractures or ligament or tendon ruptures of elbow or shoulder joints (on clinical examination)
  • Patients presented after 14 days of injury, partial or complete disability of the elbow or shoulder joint on the affected side before injury
  • Previous surgical procedure on same side
  • Presence of neurovascular complications
  • Apparent dementia or other psychological problems

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group A participants
After getting approval from ethical review board. Written informed consent will be taken. The participants will be randomly assigned two groups using lottery method. In group A, 75 Participants will undergo ORIF by using anterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months. After 3 months, plain x-ray will be done to assess the bone union . Patients will also be examined for ASES score by researcher and presence of postoperative radial nerve palsy will also be evaluated. All the data will be recorded in Performa.
Fremgangsmåte: Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixation
In group A, participants will undergo ORIF by using anterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months.
Aktiv komparator: Group B participants
After getting approval from ethical review board. Written informed consent will be taken. The participants will be randomly assigned two groups using lottery method. In group B, 75 Participants will undergo ORIF by using posterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months. After 3 months, plain x-ray will be done to assess the bone union . Patients will also be examined for ASES score by researcher and presence of postoperative radial nerve palsy will also be evaluated. All the data will be recorded in Performa.
Fremgangsmåte: Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixation
In group B, participants will undergo ORIF by using posterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Operative time
Tidsramme: 3 Months
It will be assessed by using in terms of minutes required to perform surgery from time of incision given in the skin until closure of skin with stitches.
3 Months
Bone union
Tidsramme: 3 Months
It will be labeled if there is detectable callus bridge or at least three visible cortices on radiographs
3 Months
American Shoulder and Elbow Surgeons Score (ASES)
Tidsramme: 3 Months
It will be assessed after 3 months of surgery
3 Months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dr Jahanzaib Ramay

Samarbeidspartnere

Sahiwal Teaching Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. februar 2026

Primær fullføring (Antatt)

17. august 2026

Studiet fullført (Antatt)

17. august 2026

Datoer for studieregistrering

Først innsendt

16. august 2026

Først innsendt som oppfylte QC-kriteriene

16. august 2026

Først lagt ut (Faktiske)

20. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 440

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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