TPHF: Treatment of Proximal Humeral Fractures

Sponsor

Tampere University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01246167

Collaborator

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

250

Enrollment

Locations

Arms

106

Duration (Months)

41.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Humeral Fractures, Proximal	Device: Philos Device: Epoca Other: Control group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conservative Active physiotherapy and self-training	Other: Control group Conservative control group
Active Comparator: Philos locking plate After operative treatment active physiotherapy and self-training	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.
Active Comparator: Epoca prosthesis After operative treatment active physiotherapy and self-training	Device: Epoca Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group

Arm

Intervention/Treatment

Active Comparator: Conservative

Active physiotherapy and self-training

Other: Control group

Conservative control group

Active Comparator: Philos locking plate

After operative treatment active physiotherapy and self-training

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.

Active Comparator: Epoca prosthesis

After operative treatment active physiotherapy and self-training

Device: Epoca

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

Outcome Measures

Primary Outcome Measures

DASH [6 months]
to measure physical function and symptoms of the fractured shoulder
DASH [1 year]
to measure physical function and symptoms of the fractured shoulder
DASH [2 year]
to measure physical function and symptoms of the fractured shoulder

Secondary Outcome Measures

EQ-5D [6 month]
Individual's general health related quality of life is measured with EQ-5D
EQ-5D [1 year]
Individual's general health related quality of life is measured with EQ-5D
EQ-5D [2 year]
Individual's general health related quality of life is measured with EQ-5D

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark
2	Regionaalhaigla, PERH	Tallinn		Estonia
3	Jyväskylä Central Hospital	Jyväskylä	Keski-Suomi	Finland	40620
4	Tampere University Hospital	Tampere	Pirkanmaa	Finland	33521
5	Karolinska University Hospital	Stockholm		Sweden
6	Uppsala University Hospital	Uppsala		Sweden