An interventional study of locking plate, ORIF and Hemiarthroplasty in Humeral Fracture, sponsored by University of Helsinki. Terminated at 1 site in Finland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by University of Helsinki · Not applicable, Interventional, and Treatment
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.
178 studies on the registry are indexed under Humeral Fractures; 25 are open to participants now.
This study's enrollment of 60 is close to the median of 56 across 100 interventional studies indexed under Humeral Fractures.
Browse Humeral Fractures studies →University of Helsinki is the lead sponsor of 132 studies on the registry; 19 are open to participants now.
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3- or 4-part fracture with >5mm dislocation of the anatomic neck.
Exclusion Criteria:
Other: Conservative treatment
Procedure: locking plate, ORIF
Procedure: Hemiarthroplasty
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.
Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.
Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.
Pain at rest Numeric Rating Scale 0-10 (NRS)
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Pain in active motion NRS
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Constant Score
Time frame: 3 mo, 6 mo, 1 year, 2 years
Simple Shoulder Test (SST)
Time frame: 3 mo, 6 mo, 1 year, 2 years
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 3 mo, 6 mo, 1 year, 2 years
Quality of life assessed with 15D
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Subjective satisfaction
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Complications
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
The record gives a start of Nov 2010, a primary completion of Feb 2024 and a completion of Feb 2024. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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