Hyaluronic Acid in Overuse Knee Pain
Primary Purpose
Overuse Injury
Status
Recruiting
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA
Sponsored by
About this trial
This is an interventional treatment trial for Overuse Injury focused on measuring KNEE, PAIN, SPORTSMEN, HYALURONIC ACID
Eligibility Criteria
Inclusion Criteria:
- - Patients with knee pain for more than 3 months
- Patients between 30 and 55 years old
- Patients without a history of previous knee joint surgery.
- Patients without chronic-degenerative diseases such as diabetes, hypertension, rheumatoid arthritis or other autoimmune diseases.
- Patients who perform impact social sports at least 3 times a week for more than 1 hour in the last 3 months prior to treatment.
- Patients without a history of allergies to non-steroidal anti-inflammatory drugs.
- Patients with no history of infection in or around the knee.
Exclusion Criteria:
- - Patients who cannot be categorized as social athletes.
- Patients with an associated sports injury that limits their sports practice.
- Patients who have a treatment associated with knee pain independent of that established in the study protocol.
Sites / Locations
- Issemym TlalnepantlaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyaluronic Acid group
Arm Description
All overuse knee syndrome participants after both knee joint infiltration with two doses each of Synolis VA (2ml = 40 milligrams of hyaluronic acid with 80 milligrams of sorbitol).
Outcomes
Primary Outcome Measures
Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the knee injury and osteoarthritis outcome score
To demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen decrease the pain during spots and day-living activities by measured the improvement of knee symptoms through the KOOS score:
- The Knee injury and Osteoarthritis Outcome Score: Evaluate Symptoms + Stiffness subtotal, Pain, Function, daily living, sports and recreational activities and quality of life. Each variable has a percentage score from 0 to 100%, at the end the results are averaged, obtaining a final percentage where 100% means the greatest pain and knee discomfort and 0% means the knee is healthy and without discomfort.
Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the International Knee Documentation Committee score
Demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen improves the perception of functionality in the knee of athletes through the IKDC questionaire
- The International Knee Documentation Committee: Contains sections on knee symptoms, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). 0 is the lowest score and 87 is the highest corresponding to 100%.
Secondary Outcome Measures
Safety of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome by the number of adverse effects in participants.
Evaluate the SYNOLIS VA ® safety after two doses of intra articular injection by tracking the number of patient withdrawals and their adverse events including: skin irritation, knee redness, local pain for more than 24 hours, edema for more than 48 hours and itching at the application site.
Full Information
NCT ID
NCT05450458
First Posted
June 17, 2022
Last Updated
July 4, 2022
Sponsor
Hospital Regional Tlalnepantla
1. Study Identification
Unique Protocol Identification Number
NCT05450458
Brief Title
Hyaluronic Acid in Overuse Knee Pain
Official Title
Safety and Effectiveness of Hyaluronic Acid and Sorbitol With Overuse Knee Pain in Sportsmen
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Regional Tlalnepantla
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Sports activity represents part of day living people, a knee pain originated by high demand joint activity could represent a limitation to continue sports. The aim of this clinical trial is demonstrate the effects of hyaluronic acid in sportsmen with knee pain.
Detailed Description
Sports activities have become a fundamental part of our daily life, this has led to an overuse of load joints, being the knee the most relevant. Overuse injuries of the knee result from microtrauma associated with physical activity and exercise that exceeds the strength of the cartilage tissue.
The purpose of this study is to evaluate the usefulness and safety of hyaluronic acid in athlete patients with knee overuse syndrome. Investigators hypothesis is that hyaluronic acid y safe and can improve symptoms of knee pain in sports patients. . Scores recorder data will be made at 15 days, then at 3 and 6 months after two knee injections of hyaluronic acid with sorbitol (Synolis VA).
Synolis VA is a viscoelastic, sterile, non-pyrogenic, isotonic, buffered solution of 2% hyaluronic acid. The hyaluronic acid used in synolis VA is obtained from bacterial fermentation and has a high molecular weight of 2 mdaltons, it has a neutral pH of 6.8 - 7.4 like synovial fluid. High concentration and high molecular weight of hyaluronic acid combined with sorbitol limits its degradation and confers the capacity of viscoelastic solution to restore joint lubrication and shock absorption properties.
This research protocol has been approve by the ethics and research Institutional committee in ISSEMyM Tlalnepantla Estado de Mexico number: CEI/0504/PI./2022. All participants must sign a informed consent to confirm be part fo this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overuse Injury
Keywords
KNEE, PAIN, SPORTSMEN, HYALURONIC ACID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
A study group will be integrated which will be evaluated before the intervention and after 15 days, 3 and 6 subsequent months.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic Acid group
Arm Type
Experimental
Arm Description
All overuse knee syndrome participants after both knee joint infiltration with two doses each of Synolis VA (2ml = 40 milligrams of hyaluronic acid with 80 milligrams of sorbitol).
Intervention Type
Drug
Intervention Name(s)
KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA
Other Intervention Name(s)
VISCOSUPPLEMENTATION WITH SYNOLIS VA
Intervention Description
KNEE INFILTRATION WITH HYALURONIC ACID WITH SORBITOL IN SPORTSMEN
Primary Outcome Measure Information:
Title
Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the knee injury and osteoarthritis outcome score
Description
To demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen decrease the pain during spots and day-living activities by measured the improvement of knee symptoms through the KOOS score:
- The Knee injury and Osteoarthritis Outcome Score: Evaluate Symptoms + Stiffness subtotal, Pain, Function, daily living, sports and recreational activities and quality of life. Each variable has a percentage score from 0 to 100%, at the end the results are averaged, obtaining a final percentage where 100% means the greatest pain and knee discomfort and 0% means the knee is healthy and without discomfort.
Time Frame
6 Months
Title
Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the International Knee Documentation Committee score
Description
Demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen improves the perception of functionality in the knee of athletes through the IKDC questionaire
- The International Knee Documentation Committee: Contains sections on knee symptoms, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). 0 is the lowest score and 87 is the highest corresponding to 100%.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Safety of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome by the number of adverse effects in participants.
Description
Evaluate the SYNOLIS VA ® safety after two doses of intra articular injection by tracking the number of patient withdrawals and their adverse events including: skin irritation, knee redness, local pain for more than 24 hours, edema for more than 48 hours and itching at the application site.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Patients with knee pain for more than 3 months
Patients between 30 and 55 years old
Patients without a history of previous knee joint surgery.
Patients without chronic-degenerative diseases such as diabetes, hypertension, rheumatoid arthritis or other autoimmune diseases.
Patients who perform impact social sports at least 3 times a week for more than 1 hour in the last 3 months prior to treatment.
Patients without a history of allergies to non-steroidal anti-inflammatory drugs.
Patients with no history of infection in or around the knee.
Exclusion Criteria:
- Patients who cannot be categorized as social athletes.
Patients with an associated sports injury that limits their sports practice.
Patients who have a treatment associated with knee pain independent of that established in the study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JULIO C VELEZ DE LACHICA, MD
Phone
52 5518338063
Email
activeknee@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
SUSANA SERRANO REYES, MD
Phone
52 5534714223
Email
SSUSANA.SERRANOR@GMAIL.COM
Facility Information:
Facility Name
Issemym Tlalnepantla
City
Tlanepantla
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JULIO C VELEZ DE LACHICA, MD
Phone
52 26269200
Ext
2100
Email
activeknee@gmail.com
First Name & Middle Initial & Last Name & Degree
JESUS REYES REYES, MD
Phone
5526269200
Ext
2101
Email
enseinves.hrtlalne@issemym.gob.mx
First Name & Middle Initial & Last Name & Degree
JULIO C VELEZ DE LACHICA, MD
First Name & Middle Initial & Last Name & Degree
SUSANA SERRANO REYES, MD
First Name & Middle Initial & Last Name & Degree
ANTONIO FARFAN LARA, MS
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://now.aapmr.org/knee-overuse-disorders/
Description
Tiu T, Craig Van Dien MD. Knee overuse disorders
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Hyaluronic Acid in Overuse Knee Pain
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