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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Humeral Fracture
Procedure: locking plate, ORIF
Procedure: Hemiarthroplasty
Other: Conservative treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Cost-Effectiveness of Operative and Conservative Treatment of Comminuted Fractures of the Proximal Humerus. A Randomised, Controlled Study.

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conservative Treatment 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.
Experimental: ORIF w. locking plate, no luxation 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.
Experimental: Hemiarthroplasty, no luxation Procedure: Hemiarthroplasty
Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.
Experimental: ORIF w. locking plate, Luxation-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.
Experimental: Hemiarthroplasty, Luxation-fracture Procedure: Hemiarthroplasty
Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999193

Contacts
Contact: Tuomas Lähdeoja, MD +358-40-5406501 tuomas.lahdeoja@hus.fi
Contact: Mika Paavola, MD, PhD +358-50-4272481 mika.paavola@hus.fi

Locations
Finland
Töölö Hospital Trauma Center, Helsinki University Central Hospital, Recruiting
Helsinki, Finland
Contact: Jarkko Pajarinen, MD, PhD    +358-50-4271930    jarkko.pajarinen@hus.fi   
Principal Investigator: Tuomas Lähdeoja, MD         
Sponsors and Collaborators
Helsinki University
Helsinki University Central Hospital
National Institute for Health and Welfare, Finland
Investigators
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
  More Information

No publications provided

Responsible Party: Tuomas Lahdeoja, MD, Helsinki University
ClinicalTrials.gov Identifier: NCT00999193     History of Changes
Other Study ID Numbers: HUS-428/13/03/02/08
Study First Received: October 20, 2009
Last Updated: January 22, 2012
Health Authority: Finland: Ethics Committee
Finland: National Advisory Board on Health Care Ethics

Keywords provided by Helsinki University:
Shoulder
Fracture
Locking Plate
Hemiarthroplasty
Conservative
Comminuted Proximal Humerus Fracture

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Fractures, Comminuted
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on July 20, 2014