Pegs for Osteofixation of Proximal Humeral Fractures

Completed

• Conditions: Avascular Necrosis of Humerus; Proximal Humeral Fracture; Implant Complication
• Interventions: Device: Open reduction internal fixation (ORIF) with an angular stable plate

• Registration Number: NCT04622852
• Lead Sponsor: Oslo University Hospital

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

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2020-09-01
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-07
• Study First Posted: 2020-11-10
• Study Completion: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-12
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B: Philos device	Open reduction internal fixation (ORIF) with an angular stable plate	Patients operated with angular stable plate for displaced PHF with a Philos plate
Group A: ALPS-PHP device	Open reduction internal fixation (ORIF) with an angular stable plate	Patients operated with angular stable plate for displaced PHF with an ALPS plate

Primary Outcome Measures

Name	Time	Method
Peg penetration into glenohumeral joint	12 months	Radiographic or CT verified peg penetration
Screw penetration into glenohumeral joint	12 months	Radiographic or CT verified screw penetration

Secondary Outcome Measures

Name	Time	Method
Shoulder function	12 months	Constant-Murley score
Humeral head deformation	12 months	Avascular head necrosis or Sinking
Self reported shoulder function	12 months	Oxford scoulder score
Quality of life	12 months	Generic 15D score

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway