Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kuopio University Hospital | OTHER |
| Jyväskylä Central Hospital | OTHER |
| Karolinska University Hospital | OTHER |
| Tampere University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative | Active Comparator | Active physiotherapy and self-training |
|
| Philos locking plate | Active Comparator | After operative treatment active physiotherapy and self-training |
|
| Epoca prosthesis | Active Comparator | After operative treatment active physiotherapy and self-training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philos | Device | Conservative treatment versus Philos locking plate in 2 part fracture group. Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group. |
| Measure | Description | Time Frame |
|---|---|---|
| DASH | to measure physical function and symptoms of the fractured shoulder | 6 months |
| DASH | to measure physical function and symptoms of the fractured shoulder | 1 year |
| DASH | to measure physical function and symptoms of the fractured shoulder | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D | Individual's general health related quality of life is measured with EQ-5D | 6 month |
| EQ-5D | Individual's general health related quality of life is measured with EQ-5D |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Minna Laitinen, Docent | Tampere University Hospital | Principal Investigator |
| Antti Launonen, MD | Tampere University Hospital | Study Director |
| Pekka Rissanen, Professor | Tampere University | Study Chair |
| Johanna Ojanperä, MD | Kuopio University Hospital | Study Chair |
| Vesa Lepola, MD, PhD | Tampere University Hospital | Study Chair |
| Timo Viljakka, MD | Tampere University Hospital | Study Chair |
| Ville M Mattila, Professor | Tampere 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | ||||
| Regionaalhaigla, PERH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22954329 | Background | 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. | |
| 38015877 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
| OTHER |
| Academy of Finland | OTHER |
| Uppsala University Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| Regionaalhaigla, Tallinn | UNKNOWN |
| Tartu University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
| Epoca | Device | Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group |
|
| Control group | Other | Conservative control group |
|
| 1 year |
| EQ-5D | Individual's general health related quality of life is measured with EQ-5D | 2 year |
| Study Chair |
| Kjeld Soballe, Professor | Aarhus University Hospital | Study Chair |
| Kaj Dossing, MD | Central Jutland Regional Hospital | Study Chair |
| Helle Ostergaard, Msc | Central Jutland Regional Hospital | Study Chair |
| Inger Mechlenburg, PhD | University of Aarhus | Study Chair |
| Tallinn |
| Estonia |
| Jyväskylä Central Hospital | Jyväskylä | Central Finland | 40620 | Finland |
| Tampere University Hospital | Tampere | Pirkanmaa | 33521 | Finland |
| Karolinska University Hospital | Stockholm | Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| Launonen 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. |
| 35727196 | Derived | 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. |
| 31318863 | Derived | 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. |
| D008722 | Methods |