Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

University of Helsinki

Status

Terminated

Conditions

Humeral Fracture

Treatments

Procedure: Hemiarthroplasty

Other: Conservative treatment

Procedure: locking plate, ORIF

Study type

Interventional

Funder types

Other

Identifiers

NCT00999193

HUS-428/13/03/02/08

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

65+ years old

Volunteers

No 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.