Reverse Or Nothing For Complex Proximal Humeral Fractures

Humeral Fractures Clinical Trial

Official title:

Reverse Shoulder Arthroplasty Versus Conservative Treatment For Complex Proximal Fractures in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610113
• Other study ID #: AC12-045
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2023

Study information

• Verified date: August 2023
• Source: Consorci Sanitari de l'Anoia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures

Intervention

Device:
• Reverse shoulder arthroplasty
The implantation of reverse shoulder prosthesis, and reattachment of greater and lesser tuberosities

Locations

Country	Name	City	State
Spain	Joan Miquel Noguera	Collbató	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Anoia	Germans Trias i Pujol Hospital, Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, Mobility, Strenght and Daily Life Activities. (Functional Outcome)	Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury and it ranges from 0 to 100 points. The test is divided into four subscales: pain (0 to 15 points), activities of daily living (0 to 20 points), strength (0 to 25 points) and range of motion: forward elevation (0 to 10 points), external rotation (o to 10 points), abduction (0 to 10 points) and internal rotation of the shoulder (0 to 10 points). Then, those range of motion items allocate from 0 to 40 points to the global score.; The higher the score, the higher the quality of the function.	1 year
Secondary	Number of participants with treatment-related surgical reinterventions	Number of participants with treatment-related adverse events that require an additional surgical treatment after the randomization; such as debridement, implant replacement In the control group; reinterventions will be measured by the necessity to receive a treatment for fracture sequelae such as an implantation of a shoulder prosthesis or any other surgical intervention	1 year
Secondary	Number of participants with treatment-related shoulder joint infection	Acute infection will be defined as swelling, erythema, fever, purulent discharge or increasing level of biological parameters such as C-reactive protein (CRP), white blood cell count (WBC).; Only expected in experimental/intervention group	1 year
Secondary	Number of participants with treatment-related Implant dislocation	It is defined as the number of patients in experimental arm presenting a radiological disalignement between the humeral component (stem) and the glenoid component (glenosphere).; Only expected in experimental/intervention group	1 year