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
Conditions: Proximal Humeral Fracture
Sponsor: Mikel Aburto

SCIARPA 3/4 
  
  
  
  
Prospective, non-randomized and open observational study to analyse effectiveness of 
orthopedic treatment in the management of three and four-parts proximal humeral  
fractures according to Neer´s classification. 
  
  
  
  
  
  
  
  
  
  
  
  
Madrid, October 1st 2017 
 
 

SUMMARY 
  
1. Promoter 
Orthopedic Surgery Service at Gregorio Marañón University Hospital  
  
2. Clinical trial title 
  
"Treatment of proximal humeral fractures with sling." Prospective, non-randomized and 
open study to evaluate the effectiveness of orthopedic treatment in the management 
of three and four-parts proximal humeral  fractures according to Neer´s classification. 
 
3. Principal investigators and management of your workplace 
  
Dr. Mikel Aburto Bernardo 
  
Orthopedic Surgery and Traumatology Service of the Gregorio Marañón University 
Hospital. Calle Dr. Esquerdo 28007 Madrid. 
  
4. Centres where the test is planned 
Gregorio Marañón University Hospital  
  
5. Ethical Committee for Clinical Research evaluating the trial 
CEIC of Gregorio Marañón University Hospital 
  
6. Objectives: 
1. Main: 
Evaluate the effectiveness of conservative treatment in the management of 
fractures in 3 and 4 fragments of the proximal humerus according to Neer 
classification, in patients over 75 years of age. 
  
2. Secondary: 
  

         Compare the results obtained with a historical surgical cohort that were 
treated with shoulder arthroplasty for this same pathology. 
         Evaluate possible complications from orthopedic treatment. 
  
7. Design 
  
Unicentric, prospective, non-randomized, open clinical trial comparing the effectiveness 
of the orthopaedic treatment for three and four-parts proximal humeral  fractures in a 
patient population over 75 years of age.  
  
Two treatments for these fractures will be compared secondarily: 
  
1. Shoulder arthroplasty 
2. Conservative treatment with sling followed by physiotherapy. 
  
Both options are accepted today for the management in this type of fractures. [1, 2] 
   
8. Valuation variables: 
  
1. Main: 
 
Efficiency measured by the use of 4 valuation scales: 
  
a. THE AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION SCALE 
(ASES)  
J Shoulder Elbow Surg 1994;3:347-352. 
It includes subjective information on the part of the patient and the result of a 
physical examination. It is possible to get a score with a maximum of 100 points, 
of which 50% obtain them from the subjective perception of pain and the 
activities of daily life.  
  
b. DASHe ( Disability of Arm. Shoulder and Hand)  

  Spanish version of the DASH quartet. Med Clin ( Barc).2006;127(12):441-7 
   
without valuing the professional and work module. 
  
For the final score, at least 27 of the 30 questions need to be 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 at the highest point obtained, and 
considering variations with clinical significance those exceeding 10 points.  
  
                        
                                  ( Sum of n answers) -1 x 25 
  
  
c. Constant Scale, Clin. Orthop. Relate. Res 1987:160-4.  
  
It is the most used questionnaire for shoulder evaluation. It includes a subjective 
assessment of the pain presented by the patient, up to 15 points, the ability to 
perform daily activities, up to a maximum of 20 points, objective mobility 
assessment, up to 40 points, and strength through physical examination, up to 
25. The maximum score is 100., considering results as excellent > 80, good 65-79, 
media 50-64, and bad <50. 
  
d. VAS (analog visual scale) Thong ISK, Jensen MP, Miró J, Tan G. The validity of 
pain intensity measures: what do the NRS, VAS, VRS, and FPS-R measure? Scand 
J Pain. 2018 Jan 26;18(1):99-107.  
  
It is defined as a one-dimensional scale for subjective assessment of pain by the 
patient. It consists of a straight line (usually 10 centimeters -100 millimeters-) at 
whose limits are the most extreme degrees of pain intensity, considering a score 
of 0 points for the lowest degree or absence of pain (usually referred to by the 

patient as "painless") and 100 points for the highest degree (usually referred to 
as "the worst bearable" or "worst pain imaginable"). 
The final score (between 0 and 100 points) is obtained by measuring the distance 
in millimeters between the lower end (0-point score) and the mark the patient 
points along the line. 
  
  
2. Secondary: 
  
         Comparison of the results obtained on the Constant scale with a surgical 
historical cohort that were treated by shoulder prostheses for this same 
pathology. 
         Complications arising from non-surgical treatment. 
  
9. Hypothesis 
  
NULL hypothesis : The use of non-surgical treatment for three and four-parts proximal 
humeral  fractures in elderly people (over 75 years) does not produce a statistically 
significant functional improvement. 
  
MAIN hypothesis : The use of non-surgical treatment for three and four-parts proximal 
humeral  fractures in elderly people (over 75 years) produces a statistically significant 
functional improvement. 
  
10. Population under study and total number of patients 
  
Number of patients: The cohort to study includes of 20 patients in which we have opted 
for non-surgical treatment. The historical cohort consists of 20 patients undergoing 
shoulder replacement. 
  
11. Study calendar 
  

The start date of the study will be the 1st and 2nd quarter of 2017. 
  
- Recruitment of patients: 12 months  
- Follow-up period (1 year per patient): 22-24 months 
- Data analysis: 3 and 12 months. 
  
  
 
 

BACKGROUND AND CURRENT STATE. 
  
Proximal limb fractures of the humerus are very common, representing 10% of all 
fractures, with an incidence of 6.6/1,000 people and year, with exponential increase 
from 40 years. [3-6 ] 
  
Most of these fractures do not have displacement so they are successfully treated with 
brace immobilization and subsequent rehabilitation. 
  
Fractures with displacement of the fragments require surgical management. We classify 
these fractures according to the number of fragments displaced in 1, 2, 3 and 4, 
according to the system proposed by Neer. 
  
Displaced fractures type 3 and 4 of the Neer classification affecting older patients have 
been the subject of numerous studies with the aim of establishing the most appropriate 
treatment. [7,, 8 ] 
  
Reconstruction with shoulder replacement, both inverted and anatomical, has been 
widely used as a treatment in these fractures; different studies have been launched to 
establish which of the two prosthetic models offers the best [1,, 9-13]. [14,, 15 ] 
  
  
In older patients, where functional demand is not as demanding and where shoulder 
arthroplasty may cause various, conservative management can get a good clinical 
outcome in displaced fractures affecting the humeral neck. (17) [2, 15, 16 ] 
  
  
  
JUSTIFICATION OF THE STUDY 
  
We know the result of surgical treatment for three and four-parts proximal humeral  
fractures in older patients, but it was to be established if these are superior to the results 
obtained with conservative treatment.  

  
  
 OBJECTIVES 
  
1. 
 Main: 
  
Compare the effectiveness of conservative treatment for the management of three and 
four-parts proximal humeral  fractures in patients over 75 years of age. 
  
2. 
 Secondary: 
  
         Compare the results obtained with a historical surgical cohort treated with 
shoulder prostheses for this same pathology. 
         Evaluate possible complications from orthopedic treatment. 
 
 

TYPE OF TEST AND DESIGN 
  
Selection process:  
 
Patients candidates for conservative treatment (three-week sling) will form the 
"cases" group and will be selected by the research team after their emergency care. 
They will be informed of the existence of this study and offered to participate in it; 
if they become part of the study, patients will receive orthopedic (non-surgical) 
treatment of their humeral fracture. Informed consent will then be given to the 
patient.  
 
The "control" group will be formed by patients undergoing surgical treatment who 
will be selected from a historical cohort from a previous clinical trial. (FRALUX) 
  
Patients who decline to be part of the study will receive the same treatment 
currently offered in our Traumatology Service, being able to manage their fracture 
either through surgical techniques (shoulder prostheses) or through immobilization 
and subsequent rehabilitation treatment. Assigning one treatment or another to 
each patient will depend on multiple clinical, radiological variables and the patient's 
own decision as has been made at the current time in our clinical practice.  
  
Type of control and design 
 
Prospective, open, non-randomized clinical trial in a patient population over 75 years 
of age with three and four-parts proximal humeral  fractures.  
  
  
Follow-up period  
 
Each patient will have a follow-up period of one year in which they will attend: 

1. Shoulder consultation (traumatology) 
a) At 3 weeks, sling removal and rehabilitation. 
b) 3 months ASES, CONSTANT, DASH and VAS 
c) 12 months ASES, CONSTANT, DASH and VAS 
  
2. Rehabilitation consultation 
(a) At 3 weeks: rehabilitation sessions will be guidelined. 
b) At the end of rehabilitation sessions. 
  
Selection of subjects  
  
1. Inclusion criteria 
 
1. Patients over 75 years of age. 
2. Three and four-parts proximal humeral  fractures according to Neer's classification. 
  
2. Exclusion Criteria 
  
1. Previous pathology that compromises functional recovery and collaboration in 
rehabilitative protocol (neurologycal pathology, cognitive impairment...) 
  
2. Humerus proximal limb dislocation fractures. 
  
3. Open fractures, with vascular or nerve injury. 
  
4. Polytraumatized patients 
  
Treatment description  
  
1. Surgical treatment. These patients have undergone shoulder surgery by implanting a 
reverse shoulder arthroplasty. They belong to a cohort of patients who have already 

been evaluated in a previous study and who underwent this surgery because they 
suffered a fracture in 3 or 4 fragments according to Neer's classification. 
  
2. Conservative treatment. It consists of the use of a sling for three weeks, which will be 
removed twice a day to move elbow the 1st weeks and to do Codman's pendulous 
exercises in the 2nd and 3rd week. 
  
3. Concomitant treatments 
  
Patients in the non-surgical group will undergo the same rehabilitative protocol. Physical 
therapy will start after evaluation made by rehabilitator physician after third week. 
  
Patients in the surgical group also began rehabilitative treatment from the third week 
of surgery after their visit to the rehabilitator physician. 
  
 Insurance Policy  
  
It is considered that no insurance policy is necessary as they are two techniques that are 
performed in the usual surgical practice and none of them constitute a deviation from 
the usual clinical practice. 
  
 General and particular rules for researchers  
  
Researchers shall strictly comply with the provisions of this protocol, fully completing 
the data collection sheets that will be analyzed later. The study protocol will be carried 
out in accordance with the guidelines of current legislation, in compliance with the 
standards of Good Clinical Practice and the Principles set out in the Helsinki Declaration  
 Security and confidentiality devices  
  
Patient´s confidentiality will be maintained at all times, and only the investigator will be 
able to know the patient's personal data as well as its location in case the necessary 
authorities request them according to the procedures of the legislation in force. 

  
The information disseminated and obtained by the implementation of this study is 
considered confidential and must be treated at all times as such. The subjects of the 
study will be identified only with their subject code in the study. Researchers responsible 
for the clinical trial, as well as a representative of the promoter or health authorities will 
have access to the information recorded throughout the study. In case of publication of 
the results of the study, the identity of the volunteers will not be revealed. 
  
The patient may exercise his rights to the data of the study ( ARCO rights, Organic Law 
15/1999 
) 
before 
the 
principal 
investigator, 
Mikel 
Aburto 
Bernardo 
( 
mikelaburto@hotmail.com ) 
  
Documentation file  
  
There will be a documentation file for all data, which will be kept in full on paper and on 
computer media. This file must contain the following items: 
  
1. Approval by the CEIC of the protocol and the informed consent sheet. 
2. Copy of the written consent form and protocol approved with any 
amendments if applicable. 
3. Any correspondence with the CEIC. 
4. Curriculum vitae of the principal investigator and the other researchers 
who form the research team. 
5. Registration of signatures of the members of the research team. 
6. List of participants' identity. 
7. Copies of CRDs. 
  
Terms of publication  
All information obtained during the study will be considered confidential and belong to 
the promoter, who undertakes to allow the researcher to publish the results and present 
them in scientific meetings after their consent after the study is completed and the final 
analysis is carried out. 

  
 Statistical analysis  
  
1 Sample size: Accepting an alpha risk of 5% and a beta risk of 20% in a bilateral contrast, 
20 patients are required in each group to detect a difference equal to or greater than 13 
units in the ASES scale score. The common standard deviation is assumed to be 15. 
  
2 Statistical analysis: Qualitative variables shall be expressed as absolute frequencies 
and percentages while quantitative variables shall be presented as typical means and 
deviations or as medians and inter-quarterlic range depending on their normality. 
  
Initially, the comparability of both groups will be studied to check the homogeneity of 
the randomization groups. Comparisons of the ASES scale and all other numeric 
variables between two groups will be made with student's t-test of independent 
measurements or Mann-Whitney test, as deemed appropriate. For repeated 
measurements at 3 and 12 months, the Student´s t of repeated measurements or 
Wilcoxon test shall be used. To study the association of categorical variables, the 
Pearson ji-square or Fisher exact test will be used. 
  
Differences whose p-value associated with the contrast test is less than or equal to 0.05 
shall be considered significant. Data collection will be recorded in Excel database which 
will then be exported and analyzed in the SPSS 18 statistical program.