Treatment of Proximal Humeral Fractures — TPHF  

Humeral Fractures, Proximal Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Humeral Fractures, Proximal
• Shoulder Fractures

• NCT number: NCT01246167
• Study type: Interventional
• Source: Tampere University Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Completion date: November 2019