Treatment of Proximal Humeral Fractures (TPHF)
This study is currently recruiting participants.
Verified May 2013 by Tampere University Hospital
Sponsor:
Tampere University Hospital
Collaborators:
Oulu University Hospital
Kuopio University Hospital
Turku University Hospital
Jyväskylä Central Hospital
Karolinska University Hospital
University of Tampere
Information provided by (Responsible Party):
Antti Launonen, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01246167
First received: November 15, 2010
Last updated: May 12, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Humeral Fractures, Proximal |
Device: Philos Device: Epoca Other: Control group |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A National, 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 |
Resource links provided by NLM:
Further study details as provided by Tampere University Hospital:
Primary Outcome Measures:
- DASH [ Time Frame: 6 months ] [ Designated as safety issue: No ]to measure physical function and symptoms of the fractured shoulder
- DASH [ Time Frame: 1 year ] [ Designated as safety issue: No ]to measure physical function and symptoms of the fractured shoulder
- DASH [ Time Frame: 2 year ] [ Designated as safety issue: No ]to measure physical function and symptoms of the fractured shoulder
Secondary Outcome Measures:
- EQ-5D [ Time Frame: 6 month ] [ Designated as safety issue: No ]Individual's general health related quality of life is measured with EQ-5D
- EQ-5D [ Time Frame: 1 year ] [ Designated as safety issue: No ]Individual's general health related quality of life is measured with EQ-5D
- EQ-5D [ Time Frame: 2 year ] [ Designated as safety issue: No ]Individual's general health related quality of life is measured with EQ-5D
| Estimated Enrollment: | 290 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246167
Contacts
| Contact: Antti Launonen, MD | +358 3 311 69595 | antti.launonen@pshp.fi |
Locations
| Finland | |
| Jyväskylä Central Hospital | Recruiting |
| Jyväskylä, Keski-Suomi, Finland, 40620 | |
| Contact: Juha Paloneva, MD PhD | |
| Sub-Investigator: Juha Paloneva, MD PhD | |
| Oulu University Hospital | Recruiting |
| Oulu, Lappi, Finland, 90220 | |
| Contact: Tapio Flinkkilä, Docent tapio.flinkkila@ppshp.fi | |
| Sub-Investigator: Tapio Flinkkilä, Docent | |
| Tampere University Hospital | Recruiting |
| Tampere, Pirkanmaa, Finland, 33521 | |
| Contact: Antti Launonen, MD +358 3 311 69595 antti.launonen@pshp.fi | |
| Sub-Investigator: Antti Launonen, MD | |
| Kuopio University Hospital | Recruiting |
| Kuopio, Savo, Finland, 70200 | |
| Contact: Johanna Ojanperä, MD johanna.ojanpera@kuh.fi | |
| Sub-Investigator: Johanna Ojanperä, MD | |
| Turku University Hospital | Active, not recruiting |
| Turku, Finland, 20701 | |
| Sweden | |
| Karolinska University Hospital | Active, not recruiting |
| Stockholm, Sweden | |
Sponsors and Collaborators
Tampere University Hospital
Oulu University Hospital
Kuopio University Hospital
Turku University Hospital
Jyväskylä Central Hospital
Karolinska University Hospital
University of Tampere
Investigators
| Principal Investigator: | Minna Laitinen, Docent | Tampere University Hospital |
| Study Director: | Antti Launonen, MD | Tampere University Hospital |
| Study Chair: | Pekka Rissanen, Professor | University of Tampere |
| Study Chair: | Tapio Flinkkilä, Docent | Oulu University Hospital |
| Study Chair: | Johanna Ojanperä, MD | Kuopio University Hospital |
| Study Chair: | Vesa Lepola, MD, PhD | Hatanpää Hospital |
| Study Chair: | Petra Elo, MD, PhD | Tampere University Hospital |
| Study Chair: | Timo Viljakka, MD | Tampere University Hospital |
| Study Chair: | Janne Iivanainen, MD | Tampere University Hospital |
| Study Chair: | Ville M Mattila, Docent | Tampere University Hospital |
| Study Chair: | Niko Strandberg, MD | Turku University Hospital |
| Study Chair: | Juha Paloneva, MD PhD | Jyväskylä Central Hospital |
| Study Chair: | Hans Berg, Docent | Karolinska University Hospital |
| Study Chair: | Karl-Åke Jansson, Docent | Karolinska University Hospital |
More Information
Publications:
| Responsible Party: | Antti Launonen, MD, Tampere University Hospital |
| ClinicalTrials.gov Identifier: | NCT01246167 History of Changes |
| Other Study ID Numbers: | R10127 |
| Study First Received: | November 15, 2010 |
| Last Updated: | May 12, 2013 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Tampere University Hospital:
|
Proximal humerus fracture conservative locking plate Philos Epoca prosthesis |
Additional relevant MeSH terms:
|
Fractures, Bone Humeral Fractures Shoulder Fractures Wounds and Injuries Arm Injuries |
ClinicalTrials.gov processed this record on May 19, 2013