Treatment of Proximal Humeral Fractures

Humeral Fractures, Proximal Clinical Trial

— TPHF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246167
• Other study ID #: R10127
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: November 2019

Study information

• Verified date: March 2020
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Other:
• Control group
Conservative control group

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Estonia	Regionaalhaigla, PERH	Tallinn
Finland	Jyväskylä Central Hospital	Jyväskylä	Keski-Suomi
Finland	Tampere University Hospital	Tampere	Pirkanmaa
Sweden	Karolinska University Hospital	Stockholm
Sweden	Uppsala University Hospital	Uppsala

Sponsors (10)

Lead Sponsor	Collaborator
Tampere University Hospital	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

Countries where clinical trial is conducted

Denmark,  Estonia,  Finland,  Sweden, 

References & Publications (1)

Launonen AP, Lepola V, Flinkkilä T, Strandberg N, Ojanperä J, Rissanen P, Malmivaara A, Mattila VM, Elo P, Viljakka T, Laitinen M. Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study. BMC Musculoskelet Disord. 2012 Sep 7;13:167. doi: 10.1186/1471-2474-13-167. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH	to measure physical function and symptoms of the fractured shoulder	6 months
Primary	DASH	to measure physical function and symptoms of the fractured shoulder	1 year
Primary	DASH	to measure physical function and symptoms of the fractured shoulder	2 year
Secondary	EQ-5D	Individual's general health related quality of life is measured with EQ-5D	6 month
Secondary	EQ-5D	Individual's general health related quality of life is measured with EQ-5D	1 year
Secondary	EQ-5D	Individual's general health related quality of life is measured with EQ-5D	2 year