Clinical trial NCT03610113: Reverse Or Nothing For Complex Proximal Humeral Fractures
Official title: Reverse Shoulder Arthroplasty Versus Conservative Treatment For Complex Proximal Fractures in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humeral Fractures
Keywords: Conservative treatment
Reverse shoulder arthroplasty
Proximal humeral fractures
Lead sponsor: Consorci Sanitari de l'Anoia
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
name: Parc de Salut Mar
First posted: 2018-08-01
Enrollment: 81
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reverse shoulder prosthesis has recently emerged as an acute treatment for complex proximal humeral fractures. Promising functional results have been reported in observational papers.

However, no clinical trials have yet been reported when comparing the conservative treatment to surgical treatment through the use of reverse shoulder arthroplasty.

Detailed description: Introduction The proximal humeral fractures are frequent in the investigator's environment. Among them, about 20% are considered as complex features. Conservative treatment has traditionally offered an extensive range of results. The reverse shoulder prosthesis as a treatment for acute fractures of the proximal humeral in the elderly population has changed the therapeutic approach of this acute pathology. However, high-level evidence-based studies are still not available, when comparing the conservative treatment with the treatment with reverse shoulder prosthesis.

Objective To compare the functional results and complications of elderly patients presenting acute complex fractures of the proximal humerus through two types of treatments; conservative treatment and treatment with reverse shoulder prosthesis.

Methodology A prospective, multicentre and randomized study comparing conservative treatment with the surgical treatment at two years followup by the use of functional shoulder assessment (Constant scale), complications and re-interventions associated with each treatment. The quality of life will also be analyzed through the SF-36 health questionnaire

Expected results The null hypothesis of the work is based on the appearance of non-significant differences between the two groups of the study (conservative vs. surgical treatment), concerning functional status, complications, and re-interventions

Eligibility criteria: Inclusion Criteria:

* Patients with mental conditions available for rehabilitation protocols
* Patients presenting a 3 or 4 part proximal humeral fracture

Exclusion Criteria:

* Extremely displaced fractures with no bony contact or less than 1 cm.
* Cognitive impairment (Pfeiffer test \>3)
* Shoulder dislocations
* Unable to sign informed consent or unable to respond to questionnaires
* Trauma or previous surgery of the extremity
* Open or pathological fracture
* Vascular or neurological injury associated
* Unable to collaborate with rehabilitation
* Patients with serious comorbidities that discourage surgery

Primary outcomes:
measure: Pain, Mobility, Strenght and Daily Life Activities. (Functional Outcome)
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with treatment-related surgical reinterventions
timeFrame: 1 year
measure: Number of participants with treatment-related shoulder joint infection
timeFrame: 1 year
measure: Number of participants with treatment-related Implant dislocation
timeFrame: 1 year
Other outcomes:
Locations:
city: Collbató
country: Spain
facility: Joan Miquel Noguera
state: Barcelona
Study officials:
affiliation: Parc de Salut Mar
name: Carlos Torrens, PhD
role: STUDY_DIRECTOR
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.