Treatment of Proximal Humeral Fractures (TPHF)
Primary Purpose
Humeral Fractures, Proximal
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Philos
Epoca
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Humeral Fractures, Proximal focused on measuring Proximal humerus fracture, conservative, locking plate, Philos, Hemiprosthesis
Eligibility Criteria
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
Sites / Locations
- Aarhus University Hospital
- Regionaalhaigla, PERH
- Jyväskylä Central Hospital
- Tampere University Hospital
- Karolinska University Hospital
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Conservative
Philos locking plate
Epoca prosthesis
Arm Description
Active physiotherapy and self-training
After operative treatment active physiotherapy and self-training
After operative treatment active physiotherapy and self-training
Outcomes
Primary Outcome Measures
DASH
to measure physical function and symptoms of the fractured shoulder
DASH
to measure physical function and symptoms of the fractured shoulder
DASH
to measure physical function and symptoms of the fractured shoulder
Secondary Outcome Measures
EQ-5D
Individual's general health related quality of life is measured with EQ-5D
EQ-5D
Individual's general health related quality of life is measured with EQ-5D
EQ-5D
Individual's general health related quality of life is measured with EQ-5D
Full Information
NCT ID
NCT01246167
First Posted
November 15, 2010
Last Updated
March 9, 2020
Sponsor
Tampere University Hospital
Collaborators
Kuopio University Hospital, Jyväskylä Central Hospital, Karolinska University Hospital, Tampere University, Academy of Finland, Uppsala University Hospital, Aarhus University Hospital, Regionaalhaigla, Tallinn, Tartu University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01246167
Brief Title
Treatment of Proximal Humeral Fractures
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
Collaborators
Kuopio University Hospital, Jyväskylä Central Hospital, Karolinska University Hospital, Tampere University, Academy of Finland, Uppsala University Hospital, Aarhus University Hospital, Regionaalhaigla, Tallinn, Tartu University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fractures, Proximal
Keywords
Proximal humerus fracture, conservative, locking plate, Philos, Hemiprosthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conservative
Arm Type
Active Comparator
Arm Description
Active physiotherapy and self-training
Arm Title
Philos locking plate
Arm Type
Active Comparator
Arm Description
After operative treatment active physiotherapy and self-training
Arm Title
Epoca prosthesis
Arm Type
Active Comparator
Arm Description
After operative treatment active physiotherapy and self-training
Intervention Type
Device
Intervention Name(s)
Philos
Intervention Description
Conservative treatment versus Philos locking plate in 2 part fracture group.
Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.
Intervention Type
Device
Intervention Name(s)
Epoca
Intervention Description
Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Conservative control group
Primary Outcome Measure Information:
Title
DASH
Description
to measure physical function and symptoms of the fractured shoulder
Time Frame
6 months
Title
DASH
Description
to measure physical function and symptoms of the fractured shoulder
Time Frame
1 year
Title
DASH
Description
to measure physical function and symptoms of the fractured shoulder
Time Frame
2 year
Secondary Outcome Measure Information:
Title
EQ-5D
Description
Individual's general health related quality of life is measured with EQ-5D
Time Frame
6 month
Title
EQ-5D
Description
Individual's general health related quality of life is measured with EQ-5D
Time Frame
1 year
Title
EQ-5D
Description
Individual's general health related quality of life is measured with EQ-5D
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minna Laitinen, Docent
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antti Launonen, MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pekka Rissanen, Professor
Organizational Affiliation
Tampere University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johanna Ojanperä, MD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vesa Lepola, MD, PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Timo Viljakka, MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ville M Mattila, Professor
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD PhD
Organizational Affiliation
Jyväskylä Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hans Berg, Docent
Organizational Affiliation
Karolinska University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karl-Åke Jansson, Docent
Organizational Affiliation
Karolinska University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kjeld Soballe, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kaj Dossing, MD
Organizational Affiliation
Central Jutland Regional Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helle Ostergaard, Msc
Organizational Affiliation
Central Jutland Regional Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Inger Mechlenburg, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Regionaalhaigla, PERH
City
Tallinn
Country
Estonia
Facility Name
Jyväskylä Central Hospital
City
Jyväskylä
State/Province
Keski-Suomi
ZIP/Postal Code
40620
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33521
Country
Finland
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
22954329
Citation
Launonen AP, Lepola V, Flinkkila T, Strandberg N, Ojanpera 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.
Results Reference
background
PubMed Identifier
35727196
Citation
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Results Reference
derived
PubMed Identifier
31318863
Citation
Launonen AP, Sumrein BO, Reito A, Lepola V, Paloneva J, Jonsson KB, Wolf O, Strom P, Berg HE, Fellander-Tsai L, Jansson KA, Fell D, Mechlenburg I, Dossing K, Ostergaard H, Martson A, Laitinen MK, Mattila VM; as the NITEP group. Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial. PLoS Med. 2019 Jul 18;16(7):e1002855. doi: 10.1371/journal.pmed.1002855. eCollection 2019 Jul.
Results Reference
derived
Learn more about this trial
Treatment of Proximal Humeral Fractures
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