Comparative Effectiveness and Safety of Two Hyaluronic Acid Products in Knee Osteoarthritis
A legfontosabb adatok
- Ki végzi
- Coordinación de Investigación en Salud, Mexico
- Hol
- Mexikó1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 160 fő, tervezett
- Kezdés
- 2026. nov.
- Várható befejezés
- 2027. jún.
- A vizsgálat típusa
- Megfigyeléses, 2 csoport
- A vizsgált kezelések
- Hylan G-F 20
- Cross-Linked Sodium Hyaluronate
- A regiszteradat frissítve
- 2026. november 3.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with knee osteoarthritis who still have pain after usual treatments. Their doctor has already planned a hyaluronic acid injection into the knee (Mesoheal or Synvisc).
- Életkor
- Older than 18 years (minimum 19 Years).
- Nem
- Men and women can join.
- A betegség stádiuma
- Primary knee osteoarthritis seen on exam and X-ray, Kellgren-Lawrence grade II or higher but not grade IV. Walking pain VAS score greater than 4. WOMAC score greater than 7. Able to walk.
- Korábbi kezelés
- Usual drug and non-drug treatments did not help enough. No knee injection of viscosupplementation in the previous 9 months. No corticosteroids in the previous 3 months.
A részvétel fő kizáró okai
- Grade IV joint wear in the knee, strong bow-leg or knock-knee shape, or an unstable or locking knee.
- Knee surgery in the previous 6 months.
- Other inflammatory joint disease, such as rheumatoid arthritis or psoriatic arthritis.
- Known allergy to hyaluronate or its derivatives.
- Pregnant or breastfeeding women, or people at risk of severe bleeding, such as those on blood thinners without medical supervision.
A regiszter feltételei, szó szerint
Mind a 19 feltétel megnézéseKevesebb
Ki vehet részt
- Male or female patients older than 18 years
- Clinical and radiographic evidence of primary knee osteoarthritis according to the American College of Rheumatology criteria, with Kellgren-Lawrence grade II or higher
- Pain while walking, with a Visual Analog Scale (VAS) score greater than 4
- Knee pain, stiffness, and functional impairment, with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score greater than 7
- Ambulatory patients
- Candidates for viscosupplementation according to the Mexican Social Security Institute (IMSS) Clinical Practice Guidelines
- Inadequate response to conventional pharmacological and non-pharmacological treatments
- Ability to quantify nonsteroidal anti-inflammatory drug (NSAID) consumption during follow-up visits by completing a patient diary
- Ability to provide informed consent independently
Ki nem vehet részt
- Intra-articular viscosupplementation within the previous 9 months
- Knee surgery within the previous 6 months
- Concomitant inflammatory joint diseases, including rheumatoid arthritis or psoriatic arthritis
- Systemic or intra-articular corticosteroid use within the previous 3 months
- Risk of severe bleeding, including patients receiving anticoagulant therapy without medical supervision
- Known allergy to hyaluronate or its derivatives
- Kellgren-Lawrence grade IV patellofemoral or tibiofemoral joint degeneration, or equivalent
- Significant valgus or varus knee deformities
- Knee instability, ligamentous laxity, or joint locking
- Pregnant or breastfeeding women
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
Knee osteoarthritis is a condition that causes pain, stiffness, and difficulty moving the knee. Some people continue to have symptoms despite receiving usual treatments, such as pain medications, exercise, and physical therapy.
A teljes eredeti leírásKevesebb
One treatment option is viscosupplementation, which involves injecting a gel-like substance called hyaluronic acid into the knee joint. Different products are available, but it is not clear whether they provide similar benefits, have similar side effects, or differ in cost.
The goal of this study is to compare two hyaluronic acid products, Mesoheal and Synvisc, in adults with knee osteoarthritis. The researchers want to find out:
* How well each product reduces knee pain. * How much each product improves knee movement and daily activities. * What side effects may occur. * How the costs of the two treatments compare with their benefits.
The study will include approximately 160 adults who need viscosupplementation as part of their usual medical care. Each person's doctor will choose the treatment based on their medical needs and routine clinical practice. The researchers will not assign treatments.
Participants will be followed for six months. During this time, researchers will assess changes in pain, knee function, and any side effects that may occur.
The results may help doctors and healthcare providers better understand the benefits, safety, and costs of these treatments in routine clinical care.
A vizsgálat 2 csoportja
- Hylan G-F 20 (Synvisc)
Patients with knee osteoarthritis receiving intra-articular viscosupplementation with hylan G-F 20 (Synvisc) as part of routine clinical care. The treating physician selects the product independently of the research protocol. Approximately 80 participants are expected in this cohort and will be followed for six months to evaluate clinical effectiveness and safety.
Kezelés: Hylan G-F 20
- Cross-Linked Sodium Hyaluronate (Mesoheal)
Patients with knee osteoarthritis receiving intra-articular viscosupplementation with non-animal-derived cross-linked sodium hyaluronate (Mesoheal) as part of routine clinical care. The treating physician selects the product independently of the research protocol. Approximately 80 participants are expected in this cohort and will be followed for six months to evaluate clinical effectiveness and safety.
Kezelés: Cross-Linked Sodium Hyaluronate
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Comparative Evaluation of the Clinical Effectiveness, Safety, and Cost-Effectiveness of Two Hyaluronic Acid Products for Viscosupplementation in Patients With Knee Osteoarthritis: Real-World Evidence
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2026. november 3.