Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

Humeral Fracture Clinical 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00999193
• Other study ID #: HUS-428/13/03/02/08
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2010
• Est. completion date: December 2024

Study information

• Verified date: May 2020
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fracture
• Humeral Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Töölö Hospital Trauma Center, Helsinki University Central Hospital,	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
University of Helsinki	Helsinki University Central Hospital, National Institute for Health and Welfare, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at rest Numeric Rating Scale 0-10 (NRS)		6 weeks, 3 mo, 6 mo, 1 year, 2 years
Primary	Pain in active motion NRS		6 weeks, 3 mo, 6 mo, 1 year, 2 years
Primary	Constant Score		3 mo, 6 mo, 1 year, 2 years
Secondary	Simple Shoulder Test (SST)		3 mo, 6 mo, 1 year, 2 years
Secondary	Disabilities of the Arm, Shoulder and Hand (DASH)		3 mo, 6 mo, 1 year, 2 years
Secondary	Quality of life assessed with 15D		6 weeks, 3 mo, 6 mo, 1 year, 2 years
Secondary	Subjective satisfaction		6 weeks, 3 mo, 6 mo, 1 year, 2 years
Secondary	Complications		6 weeks, 3 mo, 6 mo, 1 year, 2 years