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Evaluating the efficacy of intra-articular injection of high molecular weight hyaluronic acid and Chondroitin on the knee performance of patients with plateau fracture after surgical fixation

Protocol summary

Study aim
The aim of this study is to evaluating the efficacy of intra-articular injection of high molecular weight of hyaluronic acid/chondroitin on the knee performance and pain of patient with plateau fracture after surgical fixation.
Design
The study is a randomized blinded controlled trial with two parallel groups. Sample size is 32 which means 16 patients in each group. (phase 2-3)
Settings and conduct
A clinical trial will be conducted at Imam Hossein Hospital in Tehran on 32 patients with tibial patella fracture after fixation surgery, who will be randomly divided into 2 groups of 16 people. In one group, hyaluronic acid/chondroitin and in the other group, normal saline will be injected intra-articularly into the affected knee. The researcher and the patients are blinded to the intervention and placebo groups. An independent physician administers the injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients diagnosed with plateau fracture, aged 18-65 years old, who have signed the consent form. Exclusion criteria: pregnancy or breast feeding, osteoarthritis, osteoporosis, open fracture, diabetes, heart failure, respiratory distress, coagulopathy, active infection in the knee or surrounding tissue.
Intervention groups
In the placebo group, 3 ml of normal saline was injected intra-articularly, and in the intervention group, a syringe containing 60 mg of hyaluronic acid and 90 mg of chondroitin in 3 ml was injected intra-articularly into the involved knee joint on two occasions with an interval of two weeks in 2 weeks. And 4, after the surgical procedure, it will be injected.
Main outcome variables
Primary outcome: Visual Analogue Scale Secondary outcomes: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), range of motion (ROM)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170608034390N13
Registration date: 2024-05-30, 1403/03/10
Registration timing: prospective

Last update: 2024-05-30, 1403/03/10
Update count: 0
Registration date
2024-05-30, 1403/03/10
Registrant information
Name
Hadi Esmaily
Name of organization / entity
SBMU
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
esmaily_hadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of intra-articular injection of high molecular weight hyaluronic acid and Chondroitin on the knee performance of patients with plateau fracture after surgical fixation
Public title
The effectiveness of Hyaluronic acid/Chondroitin injection on knee performance after surgical fixation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients in the age range of 18 to 65 years with a fracture of the tibial plateau Sign the written consent form
Exclusion criteria:
Uncontrolled diabetes Severe Osteoarthritis Severe osteoporosis Open fractures Inability to perform internal fixation due to tissue damage Impossibility of performing internal fixation due to past medical history Infectious diseases in the knee joint or surrounding tissues Patients with active rheumatological disorders Pregnancy Lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups with the same proportion. Using the Block Randomization method, they will be divided into 8 blocks of 4 patients, in which the ratio of intervention and placebo distribution is the same in each block.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Researchers include investigator, physician who monitors responses to interventions, data analyzer, physician who access the eligibility of patients, controller of the study quality, and patients are all blinded. Due to the difference between the viscosity of normal saline and hyaluronic acid/Chondroitin, it is not possible to blind the physicians who inject. In order to solve the error, an independent physician will do the injections.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee School of Pharmacy and Nursing & Midwifery- Shahid Beheshti Medical Univer
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Vali Asr Av.
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2024-02-12, 1402/11/23
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.281

Health conditions studied

1

Description of health condition studied
Fracture of patella
ICD-10 code
S82.1
ICD-10 code description
Fracture of upper end of tibia

Primary outcomes

1

Description
Visual Analogue Scale (VAS) of the pain rating scales
Timepoint
Measuring the severity of pain index 2 weeks after surgery (right before the first injection), 4 weeks after surgery (right before the second injection), and 22weeks after surgery.
Method of measurement
VAS (visual analogue scale) Pain scale from 0 to 10

Secondary outcomes

1

Description
ROM (range of motion)
Timepoint
Measuring the range of motion index 2 weeks after surgery (right before the first injection), 4 weeks after surgery (right before the second injection), and 22weeks after surgery.
Method of measurement
Goniometer

2

Description
WOMAC (Western Ontario and McMaster Universities Arthritis)
Timepoint
Measuring the WOMAC index 2 weeks after surgery (right before the first injection), 4 weeks after surgery (right before the second injection), and 22weeks after surgery.
Method of measurement
Using the validated WOMAC index which contain 24 items include pain (5 questions about the visual pain with scoring from 0-10), stiffness (2 questions about the difficulty of movement with scoring from 0-8), and physical function (17 questions about the range of motion with scoring from 0-68).

Intervention groups

1

Description
Intervention group: injecting a syringe containing 40 mg of hyaluronic acid and 60 mg of chondroitin (3 ml) intra-articularly into the involved knee joint on two occasions with an interval of 2 weeks (2 and 4 weeks after surgery)
Category
Treatment - Drugs

2

Description
Control group: intra-articular injection of 3ml normal saline in the space of the knee joint
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Farzad Amouzadeh Omrani
Street address
Imam Hossein Hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Fax
Email
esmaily_hadi@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Taleghani Hospital, Shahid Arabi Ave, Yemen Ave, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
zarghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parand rostamian
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
parandviolet9@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Esmaily
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
Esmaily_hadi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parand rostamian
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
parandviolet9@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Potentially the whole data is published after participants become unidentified.
When the data will become available and for how long
The access Starts in 6 months period after publishing of the results.
To whom data/document is available
Researchers working in academic and industrial institutions.
Under which criteria data/document could be used
It can be used to carry out research work.
From where data/document is obtainable
Dr. Hadi Esmaily, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences. (Esmaily_hadi@gmail.com)
What processes are involved for a request to access data/document
It well be available with sending request. (Esmaily_hadi@gmail.com)
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