Clinical trial NCT00999193: Proximal Humeral Comminuted Fractures in the Elderly - PERCELE 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Humeral Fracture
Keywords: Shoulder
Fracture
Locking Plate
Hemiarthroplasty
Conservative
Comminuted Proximal Humerus Fracture
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Finnish Institute for Health and Welfare
First posted: 2009-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain at rest Numeric Rating Scale 0-10 (NRS)
timeFrame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
measure: Pain in active motion NRS
timeFrame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
measure: Constant Score
timeFrame: 3 mo, 6 mo, 1 year, 2 years
Secondary outcomes:
measure: Simple Shoulder Test (SST)
timeFrame: 3 mo, 6 mo, 1 year, 2 years
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 3 mo, 6 mo, 1 year, 2 years
measure: Quality of life assessed with 15D
timeFrame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
measure: Subjective satisfaction
timeFrame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
measure: Complications
timeFrame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Töölö Hospital Trauma Center, Helsinki University Central Hospital,
Study officials:
affiliation: University of Helsinki
name: Tuomas Lähdeoja, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Helsinki
name: Mika Paavola, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Helsinki
name: Jarkko Pajarinen, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Helsinki
name: Seppo Koskinen, MD, PhD
role: STUDY_CHAIR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.