NCT01246167

Treatment of Proximal Humeral Fractures

An International, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Conservative, Plate Fixation and Prosthesis in Treatment of Displaced 2, 3, and 4 Part Fractures of Proximal Humerus of 60 Years and Older Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This trial is designed to compare head-to-head conservative with operative treatment in 2 stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented fractures (MFF) meaning 3 and 4 part fractures, the comparison is between conservative treatment, operative treatment with Philos plate and operative treatment with Epoca prosthesis. Subgroup analysis will be performed in an effort to obtain limit values for specific treatment of different age and fracture groups. A cost-effectiveness analysis and comparison between different treatment modalities will be carried out. The primary outcome measure will be the DASH score and the secondary outcome measure the EQ-5D value. Recruitment period is 3 years and follow-up 2 years.

Conditions

• Humeral Fractures, Proximal

Interventions

Type	Name	Description
DEVICE	Philos	Conservative treatment versus Philos locking plate in 2 part fracture group. Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.
DEVICE	Epoca	Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group
OTHER	Control group	Conservative control group

Timeline

• Start date: 2011-01-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2010-11-23
• Last updated: 2020-03-10

Locations

6 sites across 4 countries: Denmark, Estonia, Finland, Sweden