Hyaluronic Acid in Overuse Knee Pain

July 4, 2022 updated by: Julio Carlos Velez de Lachica, Hospital Regional Tlalnepantla

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Tlanepantla, Mexico, 54055
        • Recruiting
        • Issemym Tlalnepantla
        • Contact:
        • Contact:
        • Principal Investigator:
          • JULIO C VELEZ DE LACHICA, MD
        • Sub-Investigator:
          • SUSANA SERRANO REYES, MD
        • Sub-Investigator:
          • ANTONIO FARFAN LARA, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid group
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).
Drug: KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA
KNEE INFILTRATION WITH HYALURONIC ACID WITH SORBITOL IN SPORTSMEN
Other Names:
  • VISCOSUPPLEMENTATION WITH SYNOLIS VA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the knee injury and osteoarthritis outcome score
Time Frame: 6 Months

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
Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the International Knee Documentation Committee score
Time Frame: 6 Months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome by the number of adverse effects in participants.
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Regional Tlalnepantla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 4, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI/0504/PI/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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