Treatment of Comminuted Fractures of the Proximal Humerus. A Randomised, Controlled Study

• Pain at rest Numeric Rating Scale 0-10 (NRS) [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]
• Pain in active motion NRS [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]
• Constant Score [ Time Frame: 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]

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

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.

• Procedure: locking plate, ORIF
  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.
• Procedure: 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.

• Active Comparator: Conservative Treatment
  Intervention: Other: Conservative treatment
• Experimental: ORIF w. locking plate, no luxation
  Intervention: Procedure: locking plate, ORIF
• Experimental: Hemiarthroplasty, no luxation
  Intervention: Procedure: Hemiarthroplasty
• Experimental: ORIF w. locking plate, Luxation-fracture
  Intervention: Procedure: locking plate, ORIF
• Experimental: Hemiarthroplasty, Luxation-fracture
  Intervention: Procedure: Hemiarthroplasty

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.

• Helsinki University Central Hospital
• National Institute for Health and Welfare, Finland