N/A
N=20
Orthopaedic Treatment Proximal Humeral Fractures
Proximal Humeral Fracture
Bottom Line
View on ClinicalTrials.gov: NCT03339570 ↗Enrolled (actual)
20
Serious AEs
—
Results posted
Nov 2021
Primary outcome: Primary: Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma — 40.1; 51.8 units on a scale — p=<0.01
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Orthopedic treatment for a proximal humeral fracture (Procedure)
- Age
- Older Adult · 75+ yrs
- Sex
- All
- Sponsor
- Mikel Aburto
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma |
40.1; 51.8 | <0.01 sig |
| PRIMARY ASES Scale Evaluation |
54.1; 72.4 | — |
| PRIMARY DASH Scale Evaluation |
38.6; 23.8 | — |
| PRIMARY VAS Scale Evaluation |
3.3; 1.1 | — |
| SECONDARY Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study |
70.1; 51.8 | — |
| SECONDARY Development of Osteonecrosis or Lack of Consolidation |
— | — |
Summary
Prospective non-randomized, open, unicentric observational study to compare two different treatments for Three-four parts fractures of proximal humerus (Neer's Classification) in elderly patients (over 75 years old). Both technics are: Sling inmobilization and shoulder arthroplasty.
Eligibility Criteria
Inclusion Criteria
- 75 years or older.
- 3 or 4 parts fracture (Neer's Classification).
Exclusion Criteria
- Comorbilities affecting to functional recovery.
- Fractures associating shoulder dislocation.
- Open fractures including neurovascular damage.
- Polytraumatized patients
Data sourced from ClinicalTrials.gov (NCT03339570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.