Health TrialsbyHealthPanel

Management of Proximal Humerus Fractures in Adults: a Clinical Trial

ConditionShoulder Fractures
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegional Hospital of Bolzano

About this trial

Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adults who sustained a Proximal Humerus Fracture within the last week

type of Proximal Humerus Fracture AO 11-(A2, A3), 11- (B1, B2, B3)

BMI lower than 40 Kg/m2

Disqualifiers

stress fractures

revision setting

open fractures

fractures associated with a neurologic lesion; previous fractures or bony procedure at the homolateral side

Trial population

Adults presenting at our hospital with proximal humerus fractures that meet the inclusion and exclusion criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Conservative

    Procedure/Surgery

    Conservative treatment

  • ORIF

    Procedure/Surgery

    Open surgery

  • CRPP

    Procedure/Surgery

    Minimal invasive surgery

Treatment groups

351 Participants
are divided into 3 treatment groups
Group A: Conservative1 intervention
Group B: Open Reduction Internal Fixation1 intervention
Group C: Closed Reduction Percutaneous Pinning1 intervention

Trial outcomes

Primary outcomes

1

Oxford Shoulder Score

The primary endpoint of interest will be the Oxford Shoulder Score. The Oxford Shoulder Score is a patient-reported outcome measure developed to evaluate perceived pain and quality of life in subjects who received a shoulder operation. It can be used independently from the performed surgical treatment, excluding only surgical stabilisations. As the Italian province of Bolzano is bilingual (Italian and German), the Italian and German versions of the Oxford Shoulder Score shall be administered. Both versions of the Oxford Shoulder Score are valid and reliable, with high internal consistency and reproducibility. The Oxford Shoulder Score comprises 12 items with five possible answers each: pain (four items) and quality of life (eight items). The Oxford Shoulder Score contains two subscales, pain (20 points) and activities of daily living (40 points). Scores range from 0 to 60, with a higher score being consistent with increased disability.

Time frame
6, 12, and 24 months after surgery

Secondary outcomes

1

The visual analogue scale

The visual analogue scale (VAS) is a scale used to determine the pain intensity. The minimum value is 0, the maximum value is 10, with 0 meaning no pain and 10 the worst pain imaginable.

Time frame
6, 12, and 24 months after surgery
2

Rate of complications

persistent pain, frozen shoulder, malunion, surgery, nerve damage

Time frame
6, 12, and 24 months after surgery

Other outcomes

Sponsors and contacts

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

Regional Hospital of Bolzano

Lead sponsor

Source ClinicalTrials.gov

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