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Completed

NCT Number: NCT01246167

Treatment of Proximal Humeral Fractures

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.

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Key information

Conditions

Humeral Fractures, Proximal Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Philos

Device

Conservative treatment versus Philos locking plate in 2 part fracture group.

Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.

Epoca

Device

Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group

Control Group

Other

Conservative control group

Primary outcomes

  1. DASH

    Time frame: 6 months

    to measure physical function and symptoms of the fractured shoulder

  2. DASH

    Time frame: 1 year

    to measure physical function and symptoms of the fractured shoulder

  3. DASH

    Time frame: 2 year

    to measure physical function and symptoms of the fractured shoulder

Secondary outcomes

  1. EQ-5D

    Time frame: 6 month

    Individual's general health related quality of life is measured with EQ-5D

  2. EQ-5D

    Time frame: 1 year

    Individual's general health related quality of life is measured with EQ-5D

  3. EQ-5D

    Time frame: 2 year

    Individual's general health related quality of life is measured with EQ-5D

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Academy of Finland
  • Jyväskylä Central Hospital
  • Karolinska University Hospital
  • Kuopio University Hospital
  • Regionaalhaigla, Tallinn
  • Tampere University
  • Tartu University Hospital
  • Uppsala University Hospital

Registry information

Official study 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

Acronym: TPHF

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2010
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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