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Completed

NCT Number: NCT03610113

Reverse Or Nothing For Complex Proximal Humeral Fractures

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.

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Key information

Conditions

Humeral Fractures Arm Injuries Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joan Miquel Noguera

Collbató, Barcelona, 08293, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reverse Shoulder Arthroplasty

Device

The implantation of reverse shoulder prosthesis, and reattachment of greater and lesser tuberosities

Other names: Shoulder prosthesis

Primary outcomes

  1. Pain, Mobility, Strenght and Daily Life Activities. (Functional Outcome)

    Time frame: 1 year

    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.

Secondary outcomes

  1. Number of participants with treatment-related surgical reinterventions

    Time frame: 1 year

    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

  2. Number of participants with treatment-related shoulder joint infection

    Time frame: 1 year

    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

  3. Number of participants with treatment-related Implant dislocation

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de l'Anoia

Other

Collaborators

  • Germans Trias i Pujol Hospital
  • Parc de Salut Mar

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2018
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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