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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.
The investigators propose an observational study that aims to assess:
The investigators consider this to be an observational study since it assigns a single cohort of patients a single treatment (ie non-surgical treatment). The conservative treatment for this fractures is part of routine medical care, and the object of this study is to evaluate the effect of this intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthopedic treatment | This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthopedic treatment for a proximal humeral fracture | Procedure | Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma | Changes in numeric values for the Constant shoulder function scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 3 months and 12 months from the date of the trauma. The Constant scale, also known as the ConstantMurley score, is one of the most widely used instruments to evaluate the shoulder. It was originally published in 1987 by the European Society of Shoulder and Elbow Surgeons (SECEC) as a method to compare function of the shoulder before and after a treatment. It is a system that combines the physical examination (65 points) with the subjective evaluation of the patient (35 points). The maximum score is 100 points, being from 90 to 100 excellent, from 80 to 89 good, from 70 to 79 average, and less than 70 poor. | 1 year |
| ASES Scale Evaluation | Changes in numeric values for the ASES shoulder function scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 3 months and 12 months from the date of the trauma. ASES evaluation comprises a subjective part completed by the patient and an objective part performed by doctor. The subjective includes questions about pain, symptoms of instability, and activities of daily living. The final score includes two subscales:
| 12 months |
| DASH Scale Evaluation | Changes in numeric values for the DASH scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 3 months and 12 months from the date of the trauma. DASH scale consists of 30 questions. In addition, there are two optional modules, each containing four questions, which are used to assess the symptoms and function of athletes, artists and other workers whose functional demands exceed those assessed by the DASH questionnaire. Calculating the final score is relatively complicated. To calculate the score it is necessary that at least 27 of the 30 questions have been answered. The final score is obtained by calculating the arithmetic mean of the answered questions, subtracting 1 and multiplying by 25. This calculation provides a score between 0 and 100, with the greater the disability the higher the score obtained, and considering variations with clinical significance those that exceed the 10 points. |
| Measure | Description | Time Frame |
|---|---|---|
| Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study | To compare the results of Constant scale at 12 months in the prospective cohort (non-surgical cohort) with the results already obtained in a historical cohort of 20 patients who were operated on by this same pathology in our hospital. The Constant scale, also known as the ConstantMurley score, is one of the most widely used instruments to evaluate the shoulder. It was originally published in 1987 by the European Society of Shoulder and Elbow Surgeons (SECEC) as a method to compare function of the shoulder before and after a treatment. It is a system that combines the physical examination (65 points) with the subjective evaluation of the patient (35 points). The maximum score is 100 points, being from 90 to 100 excellent, from 80 to 89 good, from 70 to 79 average, and less than 70 poor. |
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Inclusion Criteria:
Exclusion Criteria:
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Elderly population suffering proximal humeral fractures
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| Name | Affiliation | Role |
|---|---|---|
| Mikel Aburto, MD | HGU Gregorio Marañon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon | Madrid | 28007 | Spain |
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20 patients who were enrolled after being diagnosed of a three-four parts proximal humeral fracture in the Emergency room at Hospital Gregorio Maranon (Madrid, Spain) between the years 2017 and 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Orthopedic Treatment | This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months. Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Orthopedic Treatment | This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months. Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma | Changes in numeric values for the Constant shoulder function scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 3 months and 12 months from the date of the trauma. The Constant scale, also known as the ConstantMurley score, is one of the most widely used instruments to evaluate the shoulder. It was originally published in 1987 by the European Society of Shoulder and Elbow Surgeons (SECEC) as a method to compare function of the shoulder before and after a treatment. It is a system that combines the physical examination (65 points) with the subjective evaluation of the patient (35 points). The maximum score is 100 points, being from 90 to 100 excellent, from 80 to 89 good, from 70 to 79 average, and less than 70 poor. | We compared the difference in the mean value for the Constant scale measured at 3 and 12 months for the group of patients under study who treated non-surgically. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
Adverse effects were not recorded during the 12 months follow-up
No adverse effects were collected, since it is a non-invasive treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Orthopedic Treatment | This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months. Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mikel Aburto | Hospital Gregorio Maranon | 34915868000 | 7007 | mikelaburto@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2017 | Jun 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| 12 months |
| VAS Scale Evaluation | Changes in numeric values for the Changes in numeric values for the VAS scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 3 months and 12 months from the date of the trauma. VAS is defined as a one-dimensional scale for the subjective assessment of pain by the patient. It consists of a straight line (usually 10 centimeters -100 millimeters) in whose limits the most extreme degrees of pain intensity are located, considering a score of 0 points for the lowest degree or absence of pain (usually referred by the patient as "no pain") and 100 points for the highest grade (often referred to as "worst bearable" or "worst pain imaginable"). The final score (from 0 to 100 points) is obtained by measuring the distance in millimeters between the lower end (score of 0 points) and the mark indicated by the patient along the line. | 12 months |
| 12 months |
| Development of Osteonecrosis or Lack of Consolidation | Collect possible complications derived from non-surgical treatment in the prospective cohort, such as humeral head osteonecrosis or lack of consolidation. | 1 year |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All patients were recruited at Hospital Gregorio Maranon (Madrid, Spain) | Number | participants |
|
| OG000 | Orthopedic Treatment: Constant Scale Evaluation at 3 Months | This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months. Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy. |
| OG001 | Orthopedic Treatment: Constant Scale Evaluation at 12 Months | This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months. Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy. |
|
|
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| Primary | ASES Scale Evaluation | Changes in numeric values for the ASES shoulder function scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 3 months and 12 months from the date of the trauma. ASES evaluation comprises a subjective part completed by the patient and an objective part performed by doctor. The subjective includes questions about pain, symptoms of instability, and activities of daily living. The final score includes two subscales:
| We compared the difference in the mean value for the ASES scale measured at 3 and 12 months for the group of patients under study who treated non-surgically. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Primary | DASH Scale Evaluation | Changes in numeric values for the DASH scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 3 months and 12 months from the date of the trauma. DASH scale consists of 30 questions. In addition, there are two optional modules, each containing four questions, which are used to assess the symptoms and function of athletes, artists and other workers whose functional demands exceed those assessed by the DASH questionnaire. Calculating the final score is relatively complicated. To calculate the score it is necessary that at least 27 of the 30 questions have been answered. The final score is obtained by calculating the arithmetic mean of the answered questions, subtracting 1 and multiplying by 25. This calculation provides a score between 0 and 100, with the greater the disability the higher the score obtained, and considering variations with clinical significance those that exceed the 10 points. | We compared the difference in the mean value for the DASH scale measured at 3 and 12 months for the group of patients under study who treated non-surgically. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
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| Primary | VAS Scale Evaluation | Changes in numeric values for the Changes in numeric values for the VAS scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 3 months and 12 months from the date of the trauma. VAS is defined as a one-dimensional scale for the subjective assessment of pain by the patient. It consists of a straight line (usually 10 centimeters -100 millimeters) in whose limits the most extreme degrees of pain intensity are located, considering a score of 0 points for the lowest degree or absence of pain (usually referred by the patient as "no pain") and 100 points for the highest grade (often referred to as "worst bearable" or "worst pain imaginable"). The final score (from 0 to 100 points) is obtained by measuring the distance in millimeters between the lower end (score of 0 points) and the mark indicated by the patient along the line. | We compared the difference in the mean value for the VAS scale measured at 3 and 12 months for the group of patients under study who treated non-surgically. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
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| Secondary | Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study | To compare the results of Constant scale at 12 months in the prospective cohort (non-surgical cohort) with the results already obtained in a historical cohort of 20 patients who were operated on by this same pathology in our hospital. The Constant scale, also known as the ConstantMurley score, is one of the most widely used instruments to evaluate the shoulder. It was originally published in 1987 by the European Society of Shoulder and Elbow Surgeons (SECEC) as a method to compare function of the shoulder before and after a treatment. It is a system that combines the physical examination (65 points) with the subjective evaluation of the patient (35 points). The maximum score is 100 points, being from 90 to 100 excellent, from 80 to 89 good, from 70 to 79 average, and less than 70 poor. | We compared difference in the mean value for the Constant scale at 12 months between the non-surgically group and a historical cohort, which consists of a group of 20 patients with a similar fracture who received a shoulder arthroplasty. Historical cohort is part of a previous study registered in Clinical Trials under the name FRALUX34, NCT02075476 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Development of Osteonecrosis or Lack of Consolidation | Collect possible complications derived from non-surgical treatment in the prospective cohort, such as humeral head osteonecrosis or lack of consolidation. | Posted | Number | participants | 1 year |
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