Proximal Humeral FractureNCT03339570

Orthopaedic Treatment Proximal Humeral Fractures

An observational study of Proximal Humeral Fracture, run by Mikel Aburto at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 75 years and older
Conditions the study is for: Proximal Humeral Fracture
What is being tested?: Orthopedic treatment for a proximal humeral fracture
Type of treatment: Surgery or procedure
How many people: 20 participants
Where: 1 siteSpain
Study dates: 15 Nov 2017to 1 Nov 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 75 years and older
All sexes
No healthy volunteers
Older adult

Study population: Elderly population suffering proximal humeral fractures

Who may be able to join

75 years or older.
3 or 4 parts fracture (Neer's Classification).

Who cannot join

Comorbilities affecting to functional recovery.
Fractures associating shoulder dislocation.
Open fractures including neurovascular damage.
Polytraumatized patients

Trial locations and contacts

1 site in 1 country.

Spain1 site

Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon
Madrid, 28007

Other trials in Spain

About this study

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

Read the 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.

Conditions: Proximal Humeral Fracture
Being tested: Orthopedic treatment for a proximal humeral fracture
Medical subject headings: Shoulder Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Orthopedic treatment for a proximal humeral fractureProcedure or surgery
Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy.

Study groups in NCT03339570
Study group	Role	What they receive
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. Receives: Procedure: Orthopedic treatment for a proximal humeral fracture

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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:
1. Pain subscale 0-50 ASES points.
2. Function/disability subscale 0-50 ASES points. Total score 0-100 ASES points, being 0 = worse pain and functional loss/disability
Measured: 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.
Measured: 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.
Measured: 12 months

Secondary outcomes (2)

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.
Measured: 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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 20171 Nov 2020

First posted13 Nov 2017
Study start15 Nov 2017
Primary completion16 Jun 2019
Study completion1 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03339570
Sponsor's protocol ID: SCIARPA 3/4
Status last verified: Oct 2021
First submitted: 12 Sep 2017
Last updated: 16 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability

All Proximal Humeral Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03339570
Acronym / sponsor ID: SCIARPA 3/4
Conditions: Proximal Humeral Fracture
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Mikel AburtoUniversity, hospital or other
Study start: 15 Nov 2017 (actual)
Primary completion: 16 Jun 2019 (actual)
Study completion: 1 Nov 2020 (actual)
First posted: 13 Nov 2017 (actual)
Results: Posted 16 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Orthopedic treatment	–	Procedure: Orthopedic treatment for a proximal humeral fractureThis 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.

Who may qualify

Ages: 75 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: Elderly population suffering proximal humeral fractures

Key inclusion criteria (2 listed)

75 years or older.
3 or 4 parts fracture (Neer's Classification).

Key exclusion criteria (4 listed)

Comorbilities affecting to functional recovery.
Fractures associating shoulder dislocation.
Open fractures including neurovascular damage.
Polytraumatized patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Orthopedic treatment for a proximal humeral fractureOrthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy.	Procedure or surgery	Orthopedic treatment

Primary outcome

Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma
Time frame: 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.
ASES Scale Evaluation
Time frame: 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: 1. Pain subscale 0-50 ASES points. 2. Function/disability subscale 0-50 ASES points. Total score 0-100 ASES points, being 0 = worse pain and functional loss/disability
DASH Scale Evaluation
Time frame: 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.
VAS Scale Evaluation
Time frame: 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.

2 secondary outcomes

Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study
Time frame: 12 months
Development of Osteonecrosis or Lack of Consolidation
Time frame: 1 year

Results and safety

Results posted to the registry on 16 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Orthopedic Treatment	20	16

Primary outcome: Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma

Time frame: 1 year. Mean (Standard Deviation). Unit: units on a scale

Measure	Orthopedic Treatment: Constant Scale Evaluation at 3 Months n = 16	Orthopedic Treatment: Constant Scale Evaluation at 12 Months n = 16
Value	40.1 (9.6)	51.8 (12.4)

Orthopedic Treatment: Constant Scale Evaluation at 3 Months vs Orthopedic Treatment: Constant Scale Evaluation at 12 Months: Mean Difference (Final Values): 18.3, p <0.01, t-test, 2 sided

Population analysed: 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.

Primary outcome: ASES Scale Evaluation

Time frame: 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Orthopedic Treatment: ASES Scale Evaluation at 3 Months n = 16	Orthopedic Treatment: ASES Scale Evaluation at 12 Months n = 16
Value	54.1 (16.5)	72.4 (11.4)

Population analysed: 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.

Primary outcome: DASH Scale Evaluation

Time frame: 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Orthopedic Treatment: DASH Scale Evaluation at 3 Months n = 16	Orthopedic Treatment: DASH Scale Evaluation at 12 Months n = 16
Value	38.6 (20.6)	23.8 (14.8)

Population analysed: 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.

Primary outcome: VAS Scale Evaluation

Time frame: 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Orthopedic Treatment:VAS Scale Evaluation at 3 Months n = 16	Orthopedic Treatment:VAS Scale Evaluation at 12 Months n = 16
Value	3.3 (1.5)	1.1 (2.1)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse effects were not recorded during the 12 months follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Orthopedic Treatment	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Proximal Humeral Fracture

RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mikel Aburto, MD principal investigator

HGU Gregorio Marañon

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Proximal Humeral Fracture, run by Mikel Aburto at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03339570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.