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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

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

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

NCT ID

NCT00999193

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

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

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

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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