Health TrialsbyHealthPanel

Study on Outcomes of Proximal Humerus Fractures

ConditionProximal Humerus Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Massachusetts, Worcester

About this trial

Patients undergoing either operative or non-operative treatment of proximal humerus fractures will be studied with the goal of understanding which treatment modality provides optimal post-injury outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

individuals 65 years of age or older with proximal humerus fractures

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • open reduction internal fixation

    Procedure/Surgery

    treatment with open reduction and plates/screws

  • intramedullary nail

    Procedure/Surgery

    open reduction and intramedullary nail

  • reverse total shoulder arthroplasty

    Procedure/Surgery

    reverse total shoulder arthroplasty

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Operative ManagementActive comparator 3 interventions
Group B: Non-operative ManagementNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Range of Motion (ROM)

Range of Motion of the shoulder in terms of degrees of motion Assessment of forward flexion (0-180 degrees), abduction (0-90 degrees), external rotation (0-90 degrees)

Time frame
at 3 months, 6 months, 12 months, and 24 months from initiation of treatment
2

SANE

"Sane outcome" typically refers to the Single Assessment Numeric Evaluation (SANE) score, a patient-reported outcome measure used in healthcare, particularly in orthopedics. It assesses a patient's perceived function of a joint or body region by asking them to rate it on a scale of 0 to 100, where 100 represents normal function

Time frame
at 3 months, 6 months, 12 months, and 24 months following initiation of treatment
3

VAS

"VAS outcome" refers to the results obtained from using a Visual Analog Scale (VAS). The VAS is a measurement tool, typically a 10 cm or 100 mm line, where individuals indicate the intensity of a subjective experience, such as pain, by marking a point on the line. The distance from one end of the line to the patient's mark is then measured, and this measurement represents the VAS score. A higher score indicates a greater intensity of the experience being measured.

Time frame
at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
4

ASES

The American Shoulder and Elbow Surgeons scale (ASES) is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. A higher ASES score indicates better shoulder function and less pain, with a score of 100 representing the best possible outcome and a score of 0 representing the worst possible outcome.

Time frame
at 3 months, 6 months, 12 months, and 24 months following initiation of intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: