Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

NCT ID: NCT00999193

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2024-02-22

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.

Conditions

Humeral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conservative Treatment

Group Type: ACTIVE_COMPARATOR

Conservative treatment

Intervention Type: OTHER

Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.

ORIF w. locking plate, no luxation

Group Type: EXPERIMENTAL

locking plate, ORIF

Intervention Type: PROCEDURE

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.

Hemiarthroplasty, no luxation

Group Type: EXPERIMENTAL

Hemiarthroplasty

Intervention Type: PROCEDURE

Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.

Interventions

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.

Intervention Type: PROCEDURE

Hemiarthroplasty

Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Tuomas Lahdeoja

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuomas Lähdeoja, MD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Mika Paavola, MD, PhD

Role: STUDY_DIRECTOR

University of Helsinki

Jarkko Pajarinen, MD, PhD

Role: STUDY_DIRECTOR

University of Helsinki

Seppo Koskinen, MD, PhD

Role: STUDY_CHAIR

University of Helsinki

Locations

Töölö Hospital Trauma Center, Helsinki University Central Hospital,

Helsinki, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 35727196 (View on PubMed)

Other Identifiers

HUS-428/13/03/02/08

Identifier Type: -

Identifier Source: org_study_id