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Recruitment decline and research question getting outdated
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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Finnish Institute for Health and Welfare | OTHER_GOV |
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Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. The aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. The results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction and costs. The study also has a cohort follow-up of the patiens who decline randomisation.
The recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in November 2019.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Treatment | Active Comparator |
| |
| ORIF w. locking plate, no luxation | Experimental |
| |
| Hemiarthroplasty, no luxation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| locking plate, ORIF | Procedure | Open reduction of the fracture (and GH joint), internal fixation with a locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at rest Numeric Rating Scale 0-10 (NRS) | 6 weeks, 3 mo, 6 mo, 1 year, 2 years | |
| Pain in active motion NRS | 6 weeks, 3 mo, 6 mo, 1 year, 2 years | |
| Constant Score | 3 mo, 6 mo, 1 year, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Simple Shoulder Test (SST) | 3 mo, 6 mo, 1 year, 2 years | |
| Disabilities of the Arm, Shoulder and Hand (DASH) | 3 mo, 6 mo, 1 year, 2 years | |
| Quality of life assessed with 15D |
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Inclusion Criteria:
Age 65 years and older
Acute trauma: 1. randomisation (op vs cons) within 7 days of injury.
3- or 4-part fracture with >5mm dislocation of the anatomic neck.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tuomas Lähdeoja, MD | University of Helsinki | Principal Investigator |
| Mika Paavola, MD, PhD | University of Helsinki | Study Director |
| Jarkko Pajarinen, MD, PhD | University of Helsinki | Study Director |
| Seppo Koskinen, MD, PhD | University of Helsinki | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Töölö Hospital Trauma Center, Helsinki University Central Hospital, | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
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| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D062785 | Hemiarthroplasty |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Hemiarthroplasty | Procedure | Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures. |
|
| Conservative treatment | Other | Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury. |
|
| 6 weeks, 3 mo, 6 mo, 1 year, 2 years |
| Subjective satisfaction | 6 weeks, 3 mo, 6 mo, 1 year, 2 years |
| Complications | 6 weeks, 3 mo, 6 mo, 1 year, 2 years |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| D013812 | Therapeutics |