Pegs for Osteofixation of Proximal Humeral Fractures

Proximal Humeral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622852
• Other study ID #: 2017/681
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis of Humerus
• Fractures, Bone
• Humeral Fractures
• Implant Complication
• Necrosis
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

Device:
• Open reduction internal fixation (ORIF) with an angular stable plate
Operative treatment of proximal humeral fracture

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peg penetration into glenohumeral joint	Radiographic or CT verified peg penetration	12 months
Primary	Screw penetration into glenohumeral joint	Radiographic or CT verified screw penetration	12 months
Secondary	Humeral head deformation	Avascular head necrosis or Sinking	12 months
Secondary	Shoulder function	Constant-Murley score	12 months
Secondary	Self reported shoulder function	Oxford scoulder score	12 months
Secondary	Quality of life	Generic 15D score	12 months