Hyaluronic Acid in Overuse Knee Pain

Overuse Injury Clinical Trial

Official title:

Safety and Effectiveness of Hyaluronic Acid and Sorbitol With Overuse Knee Pain in Sportsmen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05450458
• Other study ID #: CEI/0504/PI/2022
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2022
• Source: Hospital Regional Tlalnepantla
• Contact: JULIO C VELEZ DE LACHICA, MD
• Phone: 52 5518338063
• Email: activeknee[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cumulative Trauma Disorders
• Overuse Injury

Intervention

Drug:
• KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA
KNEE INFILTRATION WITH HYALURONIC ACID WITH SORBITOL IN SPORTSMEN

Locations

Country	Name	City	State
Mexico	Issemym Tlalnepantla	Tlanepantla

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Regional Tlalnepantla

Country where clinical trial is conducted

Mexico, 

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 Months
Primary	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%.	6 Months
Secondary	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.	6 months

External Links

•   Tiu T, Craig Van Dien MD. Knee overuse disorders