Orthopaedic Treatment Proximal Humeral Fractures

• Sponsor: Mikel Aburto (Other)
• Overall Status: Completed
• CT.gov ID: NCT03339570
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 35.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Proximal Humeral Fracture	Procedure: Orthopedic treatment for a proximal humeral fracture

Detailed Description

The investigators propose an observational study that aims to assess:

• Primarily, the functional results of a cohort of 20 pacients presenting fractures of 3 and 4 parts of proximal humerus (according to (Neer's Classification) that will be treated orthopedically (this is, non-surgically). This patients will be recruited in the emergency room of our center, and after being diagnosed of their fracture, will be treated with a sling for three weeks and subsequent rehabilitation treatment. Our intention is to assess the function of the injured shoulder using functional scales (ASES, DASH and Constant score, and VAS scale) at the time of three and twelve months from the date of the trauma.

• Secondly the investigators want to compare the results obtained in this cohort with the results of a historical cohort of patients operated in our center with the same type of fracture. Both types of treatment (non-surgical and shoulder prosthesis) are valid for this type of fracture, and endorsed by the scientific literature.

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Orthopaedic Treatment of Proximal Humeral Fractures With Sling. Prospective , Non-randomized Open Study to Compare Two Treatments Effectiveness in the Management of Three-four Part (Neer's Classification) of Proximal Humeral Fractures
• Actual Study Start Date: Nov 15, 2017
• Actual Primary Completion Date: Jun 16, 2019
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma [1 year]

   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.

2. ASES Scale Evaluation [12 months]

   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: Pain subscale 0-50 ASES points. Function/disability subscale 0-50 ASES points. Total score 0-100 ASES points, being 0 = worse pain and functional loss/disability

3. DASH Scale Evaluation [12 months]

   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.

4. VAS Scale Evaluation [12 months]

   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.

Secondary Outcome Measures

1. Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study [12 months]

   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.

2. Development of Osteonecrosis or Lack of Consolidation [1 year]

   Collect possible complications derived from non-surgical treatment in the prospective cohort, such as humeral head osteonecrosis or lack of consolidation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 75 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon	Madrid		Spain	28007

Sponsors and Collaborators

• Mikel Aburto

Investigators

• Principal Investigator: Mikel Aburto, MD, HGU Gregorio Marañon

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 1, 2017

More Information

Publications

None provided.

• Responsible Party: Mikel Aburto, OS head of unit, Hospital General Universitario Gregorio Marañon
• ClinicalTrials.gov Identifier: NCT03339570
• Other Study ID Numbers: SCIARPA 3/4
• First Posted: Nov 13, 2017
• Last Update Posted: Nov 16, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fractures, Bone; Humeral Fractures; Shoulder Fractures

Study Results

Participant Flow

Recruitment Details	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

Arm/Group Title	Orthopedic Treatment
Arm/Group Description	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.
Period Title: Overall Study
STARTED	20
COMPLETED	16
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Orthopedic Treatment
Arm/Group Description	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.
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	16 100%
Sex: Female, Male (Count of Participants)
Female	11 68.8%
Male	5 31.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Spain	16 100%

Outcome Measures

1. Primary Outcome

Title	Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Orthopedic Treatment: Constant Scale Evaluation at 3 Months	Orthopedic Treatment: Constant Scale Evaluation at 12 Months
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (Standard Deviation) [units on a scale]	40.1 (9.6)	51.8 (12.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Orthopedic Treatment: Constant Scale Evaluation at 3 Months, Orthopedic Treatment: Constant Scale Evaluation at 12 Months
	Comments	Student's t test was used if they were variables adjusted to a normal distribution, or the Mann-Whitney U test if they were non-normal variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	ASES Scale Evaluation
Description	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: Pain subscale 0-50 ASES points. Function/disability subscale 0-50 ASES points. Total score 0-100 ASES points, being 0 = worse pain and functional loss/disability
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Orthopedic Treatment: ASES Scale Evaluation at 3 Months	Orthopedic Treatment: ASES Scale Evaluation at 12 Months
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (Standard Deviation) [units on a scale]	54.1 (16.5)	72.4 (11.4)

3. Primary Outcome

Title	DASH Scale Evaluation
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Orthopedic Treatment: DASH Scale Evaluation at 3 Months	Orthopedic Treatment: DASH Scale Evaluation at 12 Months
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (Standard Deviation) [units on a scale]	38.6 (20.6)	23.8 (14.8)

4. Primary Outcome

Title	VAS Scale Evaluation
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Orthopedic Treatment:VAS Scale Evaluation at 3 Months	Orthopedic Treatment:VAS Scale Evaluation at 12 Months
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (Standard Deviation) [units on a scale]	3.3 (1.5)	1.1 (2.1)

5. Secondary Outcome

Title	Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Surgical Cohort: Constant Scale Evaluation at 12 Months	Orthopedic Treatment: Constant Scale Evaluation at 12 Months
Arm/Group Description	The historical cohort consists of 20 patients who underwent surgery for this same pathology in our hospital, and who received a reverse total shoulder arthroplasty.	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.
Measure Participants	20	16
Mean (Standard Deviation) [units on a scale]	70.1 (10.3)	51.8 (12.4)

6. Secondary Outcome

Title	Development of Osteonecrosis or Lack of Consolidation
Description	Collect possible complications derived from non-surgical treatment in the prospective cohort, such as humeral head osteonecrosis or lack of consolidation.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orthopedic Treatment
Arm/Group Description	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.
Measure Participants	16
Number [participants]	0 0%

Adverse Events

Time Frame	Adverse effects were not recorded during the 12 months follow-up
Adverse Event Reporting Description	No adverse effects were collected, since it is a non-invasive treatment
Arm/Group Title	Orthopedic Treatment
Arm/Group Description	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.
All Cause Mortality
	Orthopedic Treatment
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Orthopedic Treatment
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Orthopedic Treatment
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.