Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

Sponsor

University of Helsinki (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00999193

Collaborator

Helsinki University Central Hospital (Other), Finnish Institute for Health and Welfare (Other)

Enrollment

Location

Arms

169

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Humeral Fracture	Procedure: locking plate, ORIF Procedure: Hemiarthroplasty Other: Conservative treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2010

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conservative Treatment	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.
Experimental: ORIF w. locking plate, no luxation	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.
Experimental: Hemiarthroplasty, no luxation	Procedure: Hemiarthroplasty Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.

Arm

Intervention/Treatment

Active Comparator: Conservative Treatment

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.

Experimental: ORIF w. locking plate, no luxation

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.

Experimental: Hemiarthroplasty, no luxation

Procedure: Hemiarthroplasty

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

Outcome Measures

Primary Outcome Measures

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]
Constant Score [3 mo, 6 mo, 1 year, 2 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.