Hyaluronic Acid in Overuse Knee Pain

Sponsor
Hospital Regional Tlalnepantla (Other)
Overall Status
Recruiting
CT.gov ID
NCT05450458
Collaborator
(none)
60
1
1
11
5.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A study group will be integrated which will be evaluated before the intervention and after 15 days, 3 and 6 subsequent months.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)
Primary Purpose:
Treatment
Official Title:
Safety and Effectiveness of Hyaluronic Acid and Sorbitol With Overuse Knee Pain in Sportsmen
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the knee injury and osteoarthritis outcome score [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.

    2. Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the International Knee Documentation Committee score [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%.

    Secondary Outcome Measures

    1. Safety of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome by the number of adverse effects in participants. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Issemym Tlalnepantla Tlanepantla Mexico 54055

    Sponsors and Collaborators

    • Hospital Regional Tlalnepantla

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Julio Carlos Velez de Lachica, Head of orthopedic surgery department, Hospital Regional Tlalnepantla
    ClinicalTrials.gov Identifier:
    NCT05450458
    Other Study ID Numbers:
    • CEI/0504/PI/2022
    First Posted:
    Jul 8, 2022
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Julio Carlos Velez de Lachica, Head of orthopedic surgery department, Hospital Regional Tlalnepantla
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 8, 2022