Trial Outcomes & Findings for Orthopaedic Treatment Proximal Humeral Fractures (NCT NCT03339570)

NCT ID: NCT03339570

Last Updated: 2021-11-16

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

1 year

Results posted on

2021-11-16

Participant Flow

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

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
20
Overall Study
COMPLETED
16
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Orthopedic Treatment
n=16 Participants
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.
Age, Categorical
<=18 years
0 Participants
n=16 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=16 Participants
Age, Categorical
>=65 years
16 Participants
n=16 Participants
Sex: Female, Male
Female
11 Participants
n=16 Participants
Sex: Female, Male
Male
5 Participants
n=16 Participants
Region of Enrollment
Spain
16 participants
n=16 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Orthopedic Treatment: Constant Scale Evaluation at 3 Months
n=16 Participants
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.
Orthopedic Treatment: Constant Scale Evaluation at 12 Months
n=16 Participants
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.
Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma
40.1 units on a scale
Standard Deviation 9.6
51.8 units on a scale
Standard Deviation 12.4

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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

Outcome measures

Outcome measures
Measure
Orthopedic Treatment: Constant Scale Evaluation at 3 Months
n=16 Participants
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.
Orthopedic Treatment: Constant Scale Evaluation at 12 Months
n=16 Participants
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.
ASES Scale Evaluation
54.1 units on a scale
Standard Deviation 16.5
72.4 units on a scale
Standard Deviation 11.4

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Orthopedic Treatment: Constant Scale Evaluation at 3 Months
n=16 Participants
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.
Orthopedic Treatment: Constant Scale Evaluation at 12 Months
n=16 Participants
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.
DASH Scale Evaluation
38.6 units on a scale
Standard Deviation 20.6
23.8 units on a scale
Standard Deviation 14.8

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Orthopedic Treatment: Constant Scale Evaluation at 3 Months
n=16 Participants
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.
Orthopedic Treatment: Constant Scale Evaluation at 12 Months
n=16 Participants
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.
VAS Scale Evaluation
3.3 units on a scale
Standard Deviation 1.5
1.1 units on a scale
Standard Deviation 2.1

SECONDARY outcome

Timeframe: 12 months

Population: 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

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.

Outcome measures

Outcome measures
Measure
Orthopedic Treatment: Constant Scale Evaluation at 3 Months
n=20 Participants
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.
Orthopedic Treatment: Constant Scale Evaluation at 12 Months
n=16 Participants
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.
Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study
70.1 units on a scale
Standard Deviation 10.3
51.8 units on a scale
Standard Deviation 12.4

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Outcome measures
Measure
Orthopedic Treatment: Constant Scale Evaluation at 3 Months
n=16 Participants
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.
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.
Development of Osteonecrosis or Lack of Consolidation
0 participants

Adverse Events

Orthopedic Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mikel Aburto

Hospital Gregorio Maranon

Phone: 34915868000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place