Investigating the effect of PMMA orthopedic cement on improving the jerk interval and daily activities after fixation of proximal humerus type 3 and 4 fractures with metaphyseal defects in patients over 50 years old.
Design
Clinical trial with control group, with parallel groups, single-blind, randomized block, on 60 patients. A software called Sealed Envelope was used for randomization
Settings and conduct
Patients referred to the orthopedic clinic of Vali Asr Arak Hospital with proximal humerus type 3 and 4 fractures with metaphyseal defects will be divided into two groups. In the intervention group, 500 cc of German BONOS bone cement will be used at the site of the metaphyseal defect during surgery. In the control group, cement material will not be used and routine surgery will be performed for the patients. In this study, the surgery will be performed by the supervisor and the orthopedic assistant will be responsible for the follow-up and follow-up of the patients. They do not know how to perform the surgery, so the participants are blinded. The corresponding assistant knows how to group patients and surgical procedures.
Participants/Inclusion and exclusion criteria
Entry criteria: type 3 and 4 proximal humerus fractures with metaphyseal defects; age over 50 years old.
Exclusion criteria: sensitivity to bone cement material; death of the patient.
Intervention groups
Patients with type 3 and 4 proximal humerus fractures with metaphyseal defects will be divided into two groups. In the intervention group, 500 cc of German BONOS bone cement will be used at the site of the metaphyseal defect during surgery. In the control group, cement will not be used and routine surgery will be performed for patients
Main outcome variables
Examination for infection; avascular necrosis; upper limb movements in the form of extension; flexion; external rotation; internal rotation; abduction and adduction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230417057939N1
Registration date:2023-06-18, 1402/03/28
Registration timing:registered_while_recruiting
Last update:2023-06-18, 1402/03/28
Update count:0
Registration date
2023-06-18, 1402/03/28
Registrant information
Name
MohameadHosein Bakhshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 6574
Email address
mhosseinbakhshi92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-12, 1402/02/22
Expected recruitment end date
2023-09-03, 1402/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of polymethylmethacrylate cement in outcome of proximal humerus fractures
Public title
Investigating the effect of PMMA on the outcome of proximal humerus type 3 and 4 fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 3 and 4 proximal humerus fractures with metaphyseal defects
Age over 50 years
Absence of chronic kidney and liver disease
Absence of cancer
Informed consent to participate in the study
Exclusion criteria:
Allergy to bone cement
Death of the patient
Any cardiorespiratory arrest during surgery
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned to two intervention groups according to the order of arrival and based on the randomization sequence that will be produced in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, by using the block method random number generation software, the randomization sequence will be produced according to the required sample size for two groups. In the beginning, all the modes that can arrange 2 letters A and B in a block of 8 are produced. Then a block will be selected randomly and by placement among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block will be placed in the main container and another block will be selected again. All these works will be done with a software called Sealed Envelope. Using this method, concealment will also be observed. The concept of concealment is the unpredictability of assigning people to groups. In fact, the researcher will not be able to predict which group the next person will be in.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single-blind - In this study, patients do not know how they are grouped and how their surgical procedures are performed, so the participants are blinded. The corresponding assistant knows how to group patients and surgical procedures.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Sardasht Ave., Chamran Blvd., Arak Town
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.ARAKMU.REC.1402.003
Health conditions studied
1
Description of health condition studied
Proximal humerus fractures
ICD-10 code
S42.2
ICD-10 code description
Fracture of upper end of humerus
Primary outcomes
1
Description
Infection
Timepoint
Two weeks after surgery, 1 month after surgery and 3 months after surgery
Method of measurement
Observation
2
Description
Range of motion (ROM)extension; flexion; external rotation; internal rotation; abduction and adductio
Timepoint
1 and 3 months after surgery
Method of measurement
Disabilities of the Arm, Shoulder and Hand; DASH Questioner
Two weeks, one month after surgery and three months after surgery
Method of measurement
Graphic observation, examination
5
Description
Screw penetration
Timepoint
Two weeks, one month after surgery and three months after surgery
Method of measurement
Graphic observation, examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with type 3 and 4 proximal humerus fractures with metaphyseal defects, 500 cc of German BONOS bone cement will be used at the site of metaphyseal defects during surgery.
Category
Treatment - Surgery
2
Description
Control group: Patients with type 3 and 4 proximal humerus fractures with metaphyseal defects will not use cement, and routine surgery will be performed for patients.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Mehran Azami
Street address
Valiasr Blvd., Valiasr hospital., Arak Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3605
Email
Mehran.azami204@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpu
Street address
Sardasht Ave., Chamran Blvd., Arak Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3506
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?