Humeral Fractures, ProximalTPHFNCT01246167
Treatment of Proximal Humeral Fractures
A study testing Philos and Epoca in people with Humeral Fractures, Proximal, run by Tampere University Hospital at 6 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Humeral Fractures, Proximal
- What is being tested?
- Philos and Epoca
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Jan 2011to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Finland2 sites
Jyväskylä Central Hospital
Jyväskylä, Central Finland, 40620
Tampere University Hospital
Tampere, Pirkanmaa, 33521
Sweden2 sites
Karolinska University Hospital
Stockholm
Uppsala University Hospital
Uppsala
About this study
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
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.
- Conditions
- Humeral Fractures, Proximal
- Being tested
- Philos, Epoca, Control group
- Keywords
- Proximal humerus fracture, conservative, locking plate, Philos, Hemiprosthesis
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhilosDevice
Conservative treatment versus Philos locking plate in 2 part fracture group.
Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.
EpocaDevice
Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group
Control groupOther
Conservative control group
| Study group | Role | What they receive |
|---|---|---|
| Conservative | Active comparator | Active physiotherapy and self-training Receives: Other: Control group |
| Philos locking plate | Active comparator | After operative treatment active physiotherapy and self-training Receives: Device: Philos |
| Epoca prosthesis | Active comparator | After operative treatment active physiotherapy and self-training Receives: Device: Epoca |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH
to measure physical function and symptoms of the fractured shoulder
Measured: 6 months
DASH
to measure physical function and symptoms of the fractured shoulder
Measured: 1 year
DASH
to measure physical function and symptoms of the fractured shoulder
Measured: 2 year
Secondary outcomes (3)
EQ-5D
Individual's general health related quality of life is measured with EQ-5D
Measured: 6 month
EQ-5D
Individual's general health related quality of life is measured with EQ-5D
Measured: 1 year
EQ-5D
Individual's general health related quality of life is measured with EQ-5D
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Humeral Fractures, ProximalStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Antti Launonen, Tampere University Hospital
- Investigators
- Minna Laitinen, Docent, Principal investigator, Tampere University HospitalAntti Launonen, MD, Study director, Tampere University HospitalPekka Rissanen, Professor, Study chair, Tampere UniversityJohanna Ojanperä, MD, Study chair, Kuopio University HospitalVesa Lepola, MD, PhD, Study chair, Tampere University HospitalTimo Viljakka, MD, Study chair, Tampere University HospitalVille M Mattila, Professor, Study chair, Tampere University HospitalJuha Paloneva, MD PhD, Study chair, Jyväskylä Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246167
- Sponsor's protocol ID
- R10127
- Acronym
- TPHF
- Status last verified
- Mar 2020
- First submitted
- 15 Nov 2010
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22954329Launonen AP, Sumrein BO, Reito A, Lepola V, Paloneva J, Berg HE, Fellander-Tsai L, Kask K, Rahnel T, Tootsi K, Martson A, Jonsson KB, Wolf O, Strom P, Dossing K, Ostergaard HK, Mechlenburg I, Mattila VM, Laitinen MK. Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3-4-part proximal humerus fractures in older patients (NITEP): An open-label randomized trial. PLoS Med. 2023 Nov 28;20(11):e1004308. doi: 10.1371/journal.pmed.1004308. eCollection 2023 Nov.
PubMed 38015877Handoll 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.
PubMed 35727196Launonen 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.
PubMed 31318863
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01246167
- Acronym / sponsor ID
- TPHF / R10127
- Conditions
- Humeral Fractures, Proximal
- Keywords
- Proximal humerus fracture, conservative, locking plate, Philos, Hemiprosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- 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
- Study start
- Jan 2011
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative | Active comparator | Other: Control groupActive physiotherapy and self-training |
| Philos locking plate | Active comparator | Device: PhilosAfter operative treatment active physiotherapy and self-training |
| Epoca prosthesis | Active comparator | Device: EpocaAfter operative treatment active physiotherapy and self-training |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhilosConservative treatment versus Philos locking plate in 2 part fracture group. Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group. | Device | Philos locking plate |
| EpocaConservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group | Device | Epoca prosthesis |
| Control groupConservative control group | Other | Conservative |
Primary outcome
DASH
Time frame: 6 months
to measure physical function and symptoms of the fractured shoulder
DASH
Time frame: 1 year
to measure physical function and symptoms of the fractured shoulder
DASH
Time frame: 2 year
to measure physical function and symptoms of the fractured shoulder
3 secondary outcomes
EQ-5D
Time frame: 6 month
EQ-5D
Time frame: 1 year
EQ-5D
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 22954329Launonen 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.
- Derived from this study: PubMed 38015877Launonen AP, Sumrein BO, Reito A, Lepola V, Paloneva J, Berg HE, Fellander-Tsai L, Kask K, Rahnel T, Tootsi K, Martson A, Jonsson KB, Wolf O, Strom P, Dossing K, Ostergaard HK, Mechlenburg I, Mattila VM, Laitinen MK. Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3-4-part proximal humerus fractures in older patients (NITEP): An open-label randomized trial. PLoS Med. 2023 Nov 28;20(11):e1004308. doi: 10.1371/journal.pmed.1004308. eCollection 2023 Nov.
- Derived from this study: PubMed 35727196Handoll 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.
- Derived from this study: PubMed 31318863Launonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minna Laitinen, Docent principal investigator
Tampere University Hospital
Antti Launonen, MD study director
Tampere University Hospital
Pekka Rissanen, Professor study chair
Tampere University
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philos and Epoca in people with Humeral Fractures, Proximal, run by Tampere University Hospital at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland, Sweden, Denmark, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01246167, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.