Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness and Cost-effectiveness of Conservative and Operative Treatment of Three- and Four-part Fractures of the Proximal Humerus. A Nested Randomised Controlled Trial and Cohort Study

Conditions
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Humeral Fracture

Intervention / Treatment
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* Procedure: locking plate, ORIF
* Procedure: Hemiarthroplasty
* Other: Conservative treatment


Participation Criteria
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Eligibility Criteria
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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. AO classification C1-2 for non-luxation fractures AO classification C3 for luxation fractures Exclusion Criteria: Head Splitting fracture Open fracture Additional fractures in the shoulder region Other injuries requiring surgical treatment Clinically significant injury of the brachial plexus or vasculature Pathological fracture associated with cancer History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc) Rheumatoid Arthritis in the shoulder requiring active treatment Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc) unwillingness to accept some of the treatment options.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative Treatment<br> | Other: Conservative treatment<br>* Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.<br>|
| Experimental: ORIF w. locking plate, no luxation<br> | Procedure: locking plate, ORIF<br>* 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.<br>|
| Experimental: Hemiarthroplasty, no luxation<br> | Procedure: Hemiarthroplasty<br>* Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Fracture, Locking Plate, Hemiarthroplasty, Conservative, Comminuted Proximal Humerus Fracture