Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

Not Applicable

Terminated

• Conditions: Humeral Fracture
• Interventions: Procedure: locking plate, ORIF; Procedure: Hemiarthroplasty; Other: Conservative treatment

• Registration Number: NCT00999193
• Lead Sponsor: University of Helsinki

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Study Start: 2010-11
• Primary Completion: 2024-02-22
• Study Completion: 2024-02-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORIF w. locking plate, no luxation	locking plate, ORIF	-
Hemiarthroplasty, no luxation	Hemiarthroplasty	-
Conservative Treatment	Conservative treatment	-

Primary Outcome Measures

Name	Time	Method
Constant Score	3 mo, 6 mo, 1 year, 2 years
Pain at rest Numeric Rating Scale 0-10 (NRS)	6 weeks, 3 mo, 6 mo, 1 year, 2 years
Pain in active motion NRS	6 weeks, 3 mo, 6 mo, 1 year, 2 years

Secondary Outcome Measures

Name	Time	Method
Subjective satisfaction	6 weeks, 3 mo, 6 mo, 1 year, 2 years
Simple Shoulder Test (SST)	3 mo, 6 mo, 1 year, 2 years
Quality of life assessed with 15D	6 weeks, 3 mo, 6 mo, 1 year, 2 years
Disabilities of the Arm, Shoulder and Hand (DASH)	3 mo, 6 mo, 1 year, 2 years
Complications	6 weeks, 3 mo, 6 mo, 1 year, 2 years

Trial Locations

Locations (1)

Töölö Hospital Trauma Center, Helsinki University Central Hospital,; 🇫🇮 Helsinki, Finland