Treatment of Proximal Humeral Fractures (TPHF)

Tampere University Hospital

Status: Completed

Conditions: Humeral Fractures, Proximal

Treatments: Device: Epoca; Device: Philos; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT01246167

R10127

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 2 part fracture where fracture line emerges through the surgical (or anatomical) neck
• Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 3 or 4 part fracture

Exclusion criteria

• Refuse to participate the study
• Less than 60 years old
• Non-independent
• Dementia and/or institutionalized
• Does no understand written and spoken guidance in either Finnish or Swedish
• Pathological fracture or previous fracture in the same proximal humerus
• Serious intoxicant dependent, eg. In first aid breathalyzer shows more than 2‰
• Other operational injury in the same upper limb
• Major nerve injury (eg. Complete radialis- or delta palsy)
• Open fracture
• Multi-trauma or -fractured patient
• Fracture dislocation or head splitting fracture
• Undisplaced fracture
• Isolated tuberculum fracture
• Fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)
• Treating surgeon considers patient unsuitable to attend the study on medical basis
• Cuff-arthropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 3 patient groups

Conservative

Active Comparator group

Description:

Active physiotherapy and self-training

Treatment:

Other: Control group

Philos locking plate

Active Comparator group

Description:

After operative treatment active physiotherapy and self-training

Treatment:

Device: Philos

Epoca prosthesis

Active Comparator group

Description:

After operative treatment active physiotherapy and self-training

Treatment:

Device: Epoca