NCT03610113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

6.9 years

First QC Date

July 16, 2018

Last Update Submit

August 28, 2023

Conditions

Humeral Fractures

Keywords

Conservative treatmentReverse shoulder arthroplastyProximal humeral fractures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of participants with treatment-related surgical reinterventions

    1 year

  • Number of participants with treatment-related shoulder joint infection

    1 year

  • Number of participants with treatment-related Implant dislocation

    1 year

Study Arms (2)

CONSERVATIVE TREATMENT

NO INTERVENTION

Conservative treatment is conceived to the use of sling for three weeks, followed by rehabilitation protocol

REVERSE ARTHROPLASTY TREATMENT

EXPERIMENTAL

This group receives a surgical intervention by the use of reverse shoulder arthroplasty through deltopectoral approach and tuberosities reattachment. It is followed by the same rehabilitation protocol than conservative treatment

Device: Reverse shoulder arthroplasty

Interventions

Reverse shoulder arthroplastyDEVICE

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

Also known as: Shoulder prosthesis
REVERSE ARTHROPLASTY TREATMENT

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joan Miquel Noguera

Collbató, Barcelona, 08293, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35727196DERIVED

MeSH Terms

Conditions

Humeral FracturesShoulder Fractures

Interventions

Shoulder Prosthesis

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, BoneShoulder Injuries

Intervention Hierarchy (Ancestors)

Joint ProsthesisProstheses and ImplantsEquipment and Supplies

Study Officials

  • Carlos Torrens, PhD

    Parc de Salut Mar

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon, Principal Investigator

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 1, 2018

Study Start

September 1, 2016

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations

ES(1)