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Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

Primary Purpose

Humeral Fracture

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
locking plate, ORIF
Hemiarthroplasty
Conservative treatment
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fracture focused on measuring Shoulder, Fracture, Locking Plate, Hemiarthroplasty, Conservative, Comminuted Proximal Humerus Fracture

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Töölö Hospital Trauma Center, Helsinki University Central Hospital,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conservative Treatment

ORIF w. locking plate, no luxation

Hemiarthroplasty, no luxation

Arm Description

Outcomes

Primary Outcome Measures

Pain at rest Numeric Rating Scale 0-10 (NRS)
Pain in active motion NRS
Constant Score

Secondary Outcome Measures

Simple Shoulder Test (SST)
Disabilities of the Arm, Shoulder and Hand (DASH)
Quality of life assessed with 15D
Subjective satisfaction
Complications

Full Information

First Posted
October 20, 2009
Last Updated
May 4, 2020
Sponsor
University of Helsinki
Collaborators
Helsinki University Central Hospital, Finnish Institute for Health and Welfare
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1. Study Identification

Unique Protocol Identification Number
NCT00999193
Brief Title
Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial
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 Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
Helsinki University Central Hospital, Finnish Institute for Health and Welfare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fracture
Keywords
Shoulder, Fracture, Locking Plate, Hemiarthroplasty, Conservative, Comminuted Proximal Humerus Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative Treatment
Arm Type
Active Comparator
Arm Title
ORIF w. locking plate, no luxation
Arm Type
Experimental
Arm Title
Hemiarthroplasty, no luxation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
locking plate, ORIF
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hemiarthroplasty
Intervention Description
Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.
Intervention Type
Other
Intervention Name(s)
Conservative treatment
Intervention Description
Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.
Primary Outcome Measure Information:
Title
Pain at rest Numeric Rating Scale 0-10 (NRS)
Time Frame
6 weeks, 3 mo, 6 mo, 1 year, 2 years
Title
Pain in active motion NRS
Time Frame
6 weeks, 3 mo, 6 mo, 1 year, 2 years
Title
Constant Score
Time Frame
3 mo, 6 mo, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Simple Shoulder Test (SST)
Time Frame
3 mo, 6 mo, 1 year, 2 years
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame
3 mo, 6 mo, 1 year, 2 years
Title
Quality of life assessed with 15D
Time Frame
6 weeks, 3 mo, 6 mo, 1 year, 2 years
Title
Subjective satisfaction
Time Frame
6 weeks, 3 mo, 6 mo, 1 year, 2 years
Title
Complications
Time Frame
6 weeks, 3 mo, 6 mo, 1 year, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuomas Lähdeoja, MD
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mika Paavola, MD, PhD
Organizational Affiliation
University of Helsinki
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jarkko Pajarinen, MD, PhD
Organizational Affiliation
University of Helsinki
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seppo Koskinen, MD, PhD
Organizational Affiliation
University of Helsinki
Official's Role
Study Chair
Facility Information:
Facility Name
Töölö Hospital Trauma Center, Helsinki University Central Hospital,
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727196
Citation
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Results Reference
derived

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Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

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