Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

May 4, 2020 updated by: Tuomas Lahdeoja, University of Helsinki

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.

The recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in November 2019.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Töölö Hospital Trauma Center, Helsinki University Central Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain at rest Numeric Rating Scale 0-10 (NRS)
Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
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
6 weeks, 3 mo, 6 mo, 1 year, 2 years
Constant Score
Time Frame: 3 mo, 6 mo, 1 year, 2 years
3 mo, 6 mo, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Simple Shoulder Test (SST)
Time Frame: 3 mo, 6 mo, 1 year, 2 years
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
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
6 weeks, 3 mo, 6 mo, 1 year, 2 years
Subjective satisfaction
Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
6 weeks, 3 mo, 6 mo, 1 year, 2 years
Complications
Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
6 weeks, 3 mo, 6 mo, 1 year, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Helsinki University Central Hospital
Finnish Institute for Health and Welfare

Investigators

  • Principal Investigator: Tuomas Lähdeoja, MD, University of Helsinki
  • Study Director: Mika Paavola, MD, PhD, University of Helsinki
  • Study Director: Jarkko Pajarinen, MD, PhD, University of Helsinki
  • Study Chair: Seppo Koskinen, MD, PhD, University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (Estimate)

October 21, 2009

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS-428/13/03/02/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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