Viewing Study NCT01246167



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Last Modification Date: 2024-10-26 @ 10:28 AM
Study NCT ID: NCT01246167
Status: COMPLETED
Last Update Posted: 2020-03-10
First Post: 2010-11-15

Brief Title: Treatment of Proximal Humeral Fractures
Sponsor: Tampere University Hospital
Organization: Tampere University Hospital

Study Overview

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
Status Verified Date: 2020-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TPHF
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None