Official Title: “Effectiveness and Cost-Effectiveness of Operative and Conservative Treatment of Comminuted Fractures of the Proximal Humerus. A Randomised, Controlled Study.”

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 osteosynthesis with Philos locking plate vs treatment with Global FX fracture hemiarthroplasty vs conservative treatment in RCT 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.

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Study Primary Completion Date: June 2014

Intervention(s) in this Clinical Trial

• Procedure: Philos locking plate, ORIF
  • Open reduction of the fracture (and GH joint), internal fixation with the Philos locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture.
• Procedure: Global FX Hemiarthroplasty
  • Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.
• Other: Conservative treatment
  • Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Conservative Treatment
• Experimental: ORIF w. Philos Plate, no luxation
• Experimental: Hemiarthroplasty, no luxation
• Experimental: ORIF w. Philos Plate, Luxation-fracture
• Experimental: Hemiarthroplasty, Luxation-fracture

Primary Measures

• Pain at rest Numeric Rating Scale 0-10 (NRS)
  • Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
    Safety Issue?: No
• Pain in active motion NRS
  • Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
    Safety Issue?: No
• Constant Score
  • Time Frame: 3 mo, 6 mo, 1 year, 2 years
    Safety Issue?: No

Secondary Measures

• Simple Shoulder Test (SST)
  • Time Frame: 3 mo, 6 mo, 1 year, 2 years
    Safety Issue?: No
• Disabilities of the Arm, Shoulder and Hand (DASH)
  • Time Frame: 3 mo, 6 mo, 1 year, 2 years
    Safety Issue?: No
• Quality of life assessed with 15D
  • Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
    Safety Issue?: No
• Subjective satisfaction
  • Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
    Safety Issue?: No
• Complications
  • Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
    Safety Issue?: Yes

Inclusion Criteria:

• Age over 65 years
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Helsinki University

Overall Clinical Trial Officials and Contacts

Tuomas Lähdeoja, MD Principal Investigator Helsinki University  

Overall Contact: Tuomas Lähdeoja, MD +358-40-5406501 tuomas.lahdeoja@hus.fi

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00999193

Study ID Number: HUS-428/13/03/02/08

ClinicalTrials.gov Identifier: NCT00999193

Health Authority: Finland: Ethics Committee