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Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

This study is currently recruiting participants.
Verified January 2017 by Tuomas Lahdeoja, Helsinki University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00999193
First Posted: October 21, 2009
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Helsinki University Central Hospital
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Tuomas Lahdeoja, Helsinki University
October 20, 2009
October 21, 2009
January 4, 2017
November 2010
December 2019   (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 ]
  • Pain in active motion NRS [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ]
  • Constant Score [ Time Frame: 3 mo, 6 mo, 1 year, 2 years ]
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 ]
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 3 mo, 6 mo, 1 year, 2 years ]
  • Quality of life assessed with 15D [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ]
  • Subjective satisfaction [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ]
  • Complications [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ]
Same as current
Not Provided
Not Provided
 
Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial
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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2021
December 2019   (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.
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
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
Not Provided
Not Provided
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: Seppo Koskinen, MD, PhD Helsinki University
Helsinki University
January 2017

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