Pegs for Osteofixation of Proximal Humeral Fractures

University of Oslo (UIO)

Status: Completed

Conditions: Proximal Humeral Fracture; Avascular Necrosis of Humerus; Implant Complication

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

Study type: Observational

Funder types: Other

Identifiers

NCT04622852

2017/681

Details and patient eligibility

About

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

Full 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

Enrollment: 38 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

38 participants in 2 patient groups

Group A: ALPS-PHP device

Description:

Patients operated with angular stable plate for displaced PHF with an ALPS plate

Treatment:

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

Group B: Philos device

Description:

Patients operated with angular stable plate for displaced PHF with a Philos plate

Treatment:

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