Clinical trial NCT03694457: Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture
Official title: Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Humeral Fracture
Aged Patient
Reversed Total Shoulder Arthroplasty
Surgical Approach
Keywords: Prospective
Randomized study
Proximal humerus fracture
Surgical treatment
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety...) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.

Detailed description: The 2 main surgical approaches in total shoulder arthroplasty (TSA) are the anterior approach (deltopectoral) and the lateral one (deltoid splitting) (18).

Their advantages and drawbacks have not been clearly evaluated in proximal humerus fracture treated with an arthroplasty.

The goal of the study is to compare the results between patients (older than 65yo) presenting a proximal humerus fracture treated with a reversed shoulder arthroplasty performed through an anterior approach or a lateral one.

Eligibility criteria: Inclusion Criteria:

* Patient older than 65yo with a proximal humerus fracture (Neer 3-4 and 2 dislcated)
* Patient registered to the national health system
* Patient able to understand information about the protocol and answer to questionnaire

Exclusion Criteria:

* Non-displaced fracture or no need of surgical treatment.
* Existing bone disease
* Infection
* Neurological deficit (axillary nerve)
* Multi-injured patients
* Patient no able to fulfill the questionnaire
* Patient refuses the study

Primary outcomes:
measure: Constant Murley Score
timeFrame: 12 months
Secondary outcomes:
measure: Quick dash score
timeFrame: 3, 6 and 12 months
measure: SF12 score
timeFrame: 3, 6 and 12 months
measure: Alder score
timeFrame: 3, 6 and 12 months
measure: The Simple Shoulder Test (SST)
timeFrame: 3, 6 and 12 months
measure: WOOS (The Western Ontario Osteosarthritis )
timeFrame: 3, 6 and 12 months
measure: intensity of pain
timeFrame: pre op, 3, 6 and 12 months
measure: Radiologic evaluation
timeFrame: pre op, 3, 6 and 12 months
measure: Complications
timeFrame: pre op, 3, 6 and 12 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Guillaume VILLATTE
role: PRINCIPAL_INVESTIGATOR
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.