N/A
N=40
Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures
A02.835.232.087.090.400.400
Bottom Line
View on ClinicalTrials.gov: NCT02075476 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score — 66; 77 score on a scale — p=0.048
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hemiarthroplasty (Procedure); reverse arthroplasty (Procedure)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Carlos Alvarez
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score |
66; 77 | 0.048 sig |
| PRIMARY Effectiveness Will be Measured for Constant Score |
53; 70 | 0.001 sig |
| PRIMARY Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score |
26; 13 | 0.011 sig |
Summary
The purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of Neer's classification.
Eligibility Criteria
Inclusion Criteria
- Patients with humeral proximal extremity fracture or fracture luxation in three or four fragments of Neer's classification.
- Patient 70 years older
- Signed informed consent.
Exclusion Criteria
- Any condition to make worse the functional recovery or avoid the patient collaboration with the rehabilitation program ( cognitive disability, neurological pathology…)
- Glenohumeral osteoarthritis
- Inflammatory arthropathies
- Previous cuff arthropatyy
- High surgical or anesthesia risk
- Any disease or condition that the investigator finds decisive for exclusion.
Data sourced from ClinicalTrials.gov (NCT02075476). 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.