Trials / Completed
CompletedNCT04821180
Psychological Health Influences the Choice of Device in Proximal Humeral Fractures
Angle Stable Plate Versus Reverse Shoulder Treatment for Proximal Humeral Fractures: Should the Psychological Health Influence the Choice of Device
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 63 (actual)
- Sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
It was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (Open Reduction and Internal Fixation) (group A) and with RSA (Reverse Shoulder Arthroplasty) (group B) for three and four-part proximal humeral fractures according to Neer classification system. One independent observer performed clinical and a psychological evaluation at one(T0), six(T1) and twelve months(T2) postoperatively. The Constant's score and The Disabilities of the Arm, Shoulder and Hand (DASH score) were used for clinical evaluation, while General Anxiety Disorder-7 (GAD-7) and Caregiver Strain Scale (CSS) were used for psychological evaluation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Three and four-part proximal humeral fractures' treatment | Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2019-01-01
- Completion
- 2021-03-01
- First posted
- 2021-03-29
- Last updated
- 2021-03-29
Source: ClinicalTrials.gov record NCT04821180. Inclusion in this directory is not an endorsement.