- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01185444
Efficacy of Three Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Function in Patients With Knee Osteoarthritis (OA)
Efficacy of 3 Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Physical Function in Patients With Knee Osteoarthritis-a Randomized Controlled Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: Viscosupplementation with intra-articular hyaluronate injections is a safe and effective treatment of knee osteoarthritis. There are several forms of hyaluronate with different origin, method of production, molecular weight, dosing instructions and possibly clinical outcomes. Most current hyaluronate products are avian in origin, and only few are bioengineered via bacterial fermentation. The purpose of this study was to evaluate the efficacy and safety of 3 weekly injections of a bacterial-sourced hyaluronate (Hya-Joint) in patients with knee osteoarthritis.
Methods: As a prospective randomized observer-blind study done in a university-affiliated tertiary care medical center, patients with knee osteoarthritis for at least 6 months were enrolled. Eligible patients were randomized to receive three weekly intraarticular injections of either bacterial-sourced hyaluronate (Hya-Joint) or avian-derived hyaluronate (Hyalgan) into the target knee. The primary outcome was the visual analog scale (VAS) change from baseline for knee pain at 6-month follow-up. Secondary outcome measures included Lequesne index, timed up and go test (TUG), patients' global satisfaction and analgesics consumption.
Results: A total of 95 participants were randomly assigned and 89 participants completed the study. Both groups had significant improvements in pain as early as 1 and 2 weeks after the first injection, and the pain-reduction effects could last for 6 months, with no between-group differences. The Lequesne index scores and results of TUG tests improved significantly from baseline in both group at all follow-up visits (p<0.001 for each test compared with baseline), with no significant between-group differences at 1-month and 6-month follow-up. However, significantly greater improvements favoring the Hya-Joint group were noted at 3-month follow-up (p<0.05). No between-group differences were seen regarding the use of analgesics. Both groups reported high satisfaction at 6-month follow-up. No serious adverse events occurred.
Conclusions: Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide rapid pain relief as early as 1 and 2 weeks after the first injection, and improve function in patients with knee osteoarthritis. The treatment effects can last for 6 months.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
-
Kaohsiung, Taïwan, 813
- Department of Physical Medicine and Rehabilitation, Veterans General Hospital,
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- (1) age 40 years or older, presence of a primary knee OA with knee pain for at least 6 months despite conservative treatment (rest, physical therapy, orthoses or pain medications etc.); (2) had average pain on knee movement of at least 3 cm on a 10-cm VAS; (3) had a current Lequesne index score (described below) >7 (possible range, 0-24); (4) were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (except for rescue medication) for the duration of the study; and (5) were willing to not receive physical therapy or trial of shoe modifications or orthoses during the study period.
Exclusion Criteria:Exclusion criteria included previous orthopedic surgery on the spine or lower limbs, knee instability or marked deformity on examination, clinically apparent tense effusion of the knee, intra-articular steroid or HA injection in any joint within the past 6 months, and concomitant inflammatory arthropathy or other rheumatologic, neurological, cardiovascular or psychiatric disorders that would interfere with the clinical assessment during the study period.
-
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Hya-Joint
The Hya-Joint group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hya-Joint, derived from Streptococcus zooepidemicus and produced by a highly purified biologic fermentation process, molecular weight 650-1200 kDa),into the target knee.
|
The Hya-Joint group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hya-Joint, derived from Streptococcus zooepidemicus and produced by a highly purified biologic fermentation process, molecular weight 650-1200 kDa),into the target knee.
|
Comparateur actif: Hyalgan
the control group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (, extracted from chicken combs, molecular weight 500-730kDa) into the knee joints.
|
The control group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan, extracted from chicken combs, molecular weight 500-730kDa) into the knee joints.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
visual analog scale
Délai: 6 months after the third injection
|
The patient rated the intensity of pain with regard to average pain on knee movement over the previous week using a 10-cm horizontal VAS (10-cm line; 0= no pain to 10= worst imaginable pain)
|
6 months after the third injection
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Lequesne index
Délai: 6 months after the third injection
|
Lequesne index was used to assess severity of knee symptoms during the last week23.
It is validated and includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items).
Maximal score is 24 and higher scores represent worse function
|
6 months after the third injection
|
Timed " Up-and-Go" test
Délai: 6 months after the third injection.
|
Timed " Up-and-Go" test (TUG) is a simple test of basic physical functional mobility for frail elderly persons with high interrater reliability and content reliability24.
A patient is asked to rise from an armchair, walk 3 meters at a safe and comfortable pace, turn around, walk back to the chair, and sit down again.
The whole procedure is demonstrated first before the actual test.
The score is the time in seconds it takes to complete these tasks
|
6 months after the third injection.
|
the level of global satisfaction
Délai: 6 months after the third injection.
|
Patients were asked to rate the level of global satisfaction compared to their preinjection condition at each follow-up visit.
The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat dissatisfied, dissatisfied to completely dissatisfied.
|
6 months after the third injection.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shu-Fen Sun, MD, Veterans General Hospital, Kaohsiung;National Yang-Ming University School of Medicine, Taiwan
- Chercheur principal: Chien-Wei Hsu, MD, Department of Internal Medicine, Kaohsiung Veterans General Hospital
- Chercheur principal: Hsien-Pin Sun, MD, Cheng Ching Hospital, Taiwan
- Chercheur principal: Hung-Ju Li, MS, Institute of Statistics, National University of Kaohsiung, Taiwan
- Chercheur principal: Jue-Long Wang, MD, Kaohsiung Veterans General Hospital, Taiwan
Publications et liens utiles
Publications générales
- Sun SF, Hsu CW, Hwang CW, Hsu PT, Wang JL, Tsai SL, Chou YJ, Hsu YW, Huang CM, Wang YL. Hyaluronate improves pain, physical function and balance in the geriatric osteoarthritic knee: a 6-month follow-up study using clinical tests. Osteoarthritis Cartilage. 2006 Jul;14(7):696-701. doi: 10.1016/j.joca.2006.01.010. Epub 2006 Mar 6.
- Adams ME, Atkinson MH, Lussier AJ, Schulz JI, Siminovitch KA, Wade JP, Zummer M. The role of viscosupplementation with hylan G-F 20 (Synvisc) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Osteoarthritis Cartilage. 1995 Dec;3(4):213-25. doi: 10.1016/s1063-4584(05)80013-5.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- VGHKS97-CT9-12
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Hya-Joint
-
UnicoCell Biomed CO. LTDA2 Healthcare Taiwan CorporationComplété
-
SK Chemicals Co., Ltd.ComplétéArthrose du genouCorée, République de
-
Taiwan Bio Therapeutics Co., Ltd.A2 Healthcare Taiwan CorporationActif, ne recrute pasArthrose, GenouTaïwan
-
Assistance Publique - Hôpitaux de ParisComplétéTumeurs pulmonaires | Tubes thoraciques | Procédures chirurgicales pulmonaires | Adhésifs tissulaires | Agrafeuses chirurgicalesFrance
-
Centre Hospitalier Departemental VendeeRésilié
-
The Second Hospital of QinhuangdaoComplétéBlessure à la plaque palmaire, pouce, articulation métacarpo-phalangienneChine
-
Terumo Medical CorporationComplété
-
Sealantis Ltd.Complété
-
Joint AcademyLund UniversityRecrutementArthrose de la main | Arthrose du pouce | Arthrose du poignet | Arthrose des doigtsSuède
-
Xiongjing JiangRecrutementMaladies vasculaires périphériques | Intervention percutanée via l'artère fémoraleChine