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OpenTrials
Completed

NCT Number: NCT04622852

Pegs for Osteofixation of Proximal Humeral Fractures

Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)

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Key information

Conditions

Implant Complication Avascular Necrosis of Humerus Bone Diseases Fractures, Bone Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Proximal Humeral Fracture Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, Norway

About this study

From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events:

  • Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and
  • Avascular head necrosis / sinking / need of re-surgery
  • Clinical PROMS

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion Criterion:

  • Acute proximal humeral fracture
  • AO/OTA type 11-B2 or 11C2

Exclusion criteria

  • Not eligible to surgical treatment
  • Non-compliant
  • Former shoulder fracture or symptomatic shoulder illness
  • Drug abuser

Treatment and study plan

Open reduction internal fixation (ORIF) with an angular stable plate

Device

Operative treatment of proximal humeral fracture

Primary outcomes

  1. Peg penetration into glenohumeral joint

    Time frame: 12 months

    Radiographic or CT verified peg penetration

  2. Screw penetration into glenohumeral joint

    Time frame: 12 months

    Radiographic or CT verified screw penetration

Secondary outcomes

  1. Humeral head deformation

    Time frame: 12 months

    Avascular head necrosis or Sinking

  2. Shoulder function

    Time frame: 12 months

    Constant-Murley score

  3. Self reported shoulder function

    Time frame: 12 months

    Oxford scoulder score

  4. Quality of life

    Time frame: 12 months

    Generic 15D score

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Are Pegs Better Than Screw for Osteofixation of Proximal Humeral Fractures?

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Nov 10, 2020
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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