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Pegs for Osteofixation of Proximal Humeral Fractures

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04622852
Enrollment
38
Registered
2020-11-10
Start date
2017-07-01
Completion date
2021-08-01
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avascular Necrosis of Humerus, Implant Complication, Proximal Humeral Fracture

Keywords

Humeral head, Screw penetration, Peg penetration, Avascular necrosis

Brief summary

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

Detailed description

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: 1. Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and 2. Avascular head necrosis / sinking / need of re-surgery 3. Clinical PROMS

Interventions

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

Operative treatment of proximal humeral fracture

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Peg penetration into glenohumeral joint12 monthsRadiographic or CT verified peg penetration
Screw penetration into glenohumeral joint12 monthsRadiographic or CT verified screw penetration

Secondary

MeasureTime frameDescription
Humeral head deformation12 monthsAvascular head necrosis or Sinking
Shoulder function12 monthsConstant-Murley score
Self reported shoulder function12 monthsOxford scoulder score
Quality of life12 monthsGeneric 15D score

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026