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Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

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. Identifier: NCT00999193
Recruitment Status : Recruiting
First Posted : October 21, 2009
Last Update Posted : June 5, 2018
Helsinki University Central Hospital
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Tuomas Lahdeoja, Helsinki University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Humeral Fracture Procedure: locking plate, ORIF Procedure: Hemiarthroplasty Other: Conservative treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Pain at rest Numeric Rating Scale 0-10 (NRS) [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ]
  2. Pain in active motion NRS [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ]
  3. Constant Score [ Time Frame: 3 mo, 6 mo, 1 year, 2 years ]

Secondary Outcome Measures :
  1. Simple Shoulder Test (SST) [ Time Frame: 3 mo, 6 mo, 1 year, 2 years ]
  2. Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 3 mo, 6 mo, 1 year, 2 years ]
  3. Quality of life assessed with 15D [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ]
  4. Subjective satisfaction [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ]
  5. Complications [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00999193

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Contact: Tuomas Lähdeoja, MD +358-40-5406501
Contact: Mika Paavola, MD, PhD +358-50-4272481

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Töölö Hospital Trauma Center, Helsinki University Central Hospital, Recruiting
Helsinki, Finland
Contact: Jarkko Pajarinen, MD, PhD    +358-50-4271930   
Principal Investigator: Tuomas Lähdeoja, MD         
Sponsors and Collaborators
Helsinki University
Helsinki University Central Hospital
National Institute for Health and Welfare, Finland
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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

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Responsible Party: Tuomas Lahdeoja, MD, Helsinki University Identifier: NCT00999193     History of Changes
Other Study ID Numbers: HUS-428/13/03/02/08
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Keywords provided by Tuomas Lahdeoja, Helsinki University:
Locking Plate
Comminuted Proximal Humerus Fracture
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries