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

This study is currently recruiting participants.
Verified January 2012 by Helsinki University
Sponsor:
Collaborators:
Helsinki University Central Hospital
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Tuomas Lahdeoja, Helsinki University
ClinicalTrials.gov Identifier:
NCT00999193
First received: October 20, 2009
Last updated: January 22, 2012
Last verified: January 2012

October 20, 2009
January 22, 2012
November 2010
November 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00999193 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Treatment of Comminuted Fractures of the Proximal Humerus. A Randomised, Controlled Study
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 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Humeral Fracture
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
November 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact: Tuomas Lähdeoja, MD +358-40-5406501 tuomas.lahdeoja@hus.fi
Contact: Mika Paavola, MD, PhD +358-50-4272481 mika.paavola@hus.fi
Finland
 
NCT00999193
HUS-428/13/03/02/08
No
Tuomas Lahdeoja, Helsinki University
Helsinki University
  • Helsinki University Central Hospital
  • National Institute for Health and Welfare, Finland
Principal Investigator: Tuomas Lähdeoja, MD Helsinki University
Study Director: Mika Paavola, MD, PhD Helsinki University
Study Director: Jarkko Pajarinen, MD, PhD Helsinki University
Study Chair: Ilkka Sinisaari, Md, PhD Helsinki University
Study Chair: Vesa Savolainen, MD, PhD Helsinki University
Study Chair: Jan-Magnus Björkenheim, MD, PhD Helsinki University
Study Chair: Seppo Koskinen, MD, PhD Helsinki University
Study Chair: Robert Björkenheim, MD Helsinki University
Helsinki University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP