Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

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

Interventions

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.

PROCEDURE

Hemiarthroplasty

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

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.

Sponsors & Collaborators

• Helsinki University Central Hospital

  collaborator OTHER

• Finnish Institute for Health and Welfare

  collaborator OTHER_GOV

• University of Helsinki

  lead OTHER

Principal Investigators

• Tuomas Lähdeoja, MD · University of Helsinki

• Mika Paavola, MD, PhD · University of Helsinki

• Jarkko Pajarinen, MD, PhD · University of Helsinki

• Seppo Koskinen, MD, PhD · University of Helsinki

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-11-30

Primary Completion

2024-02-22

Completion

2024-02-22

Countries

• Finland

Study Locations