Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078351
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-02-23
Brief Title:
Synvisc to Treat Osteoarthritis of the Temporomandibular Joint
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of Viscosupplementation Using Synvisc in Symptomatic Osteoarthritis of the Temporomandibular Joint
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effectiveness of injected hylan Synvisc for treating pain associated with osteoarthritis of the temporomandibular joint jaw joint and improving function of the joint Hylan is a synthetic product very similar to a component of normal healthy joint fluid synovial fluid which is present in much lower quantities and is abnormal in osteoarthritis Hylan injections have been beneficial in treating osteoarthritis of the knee
Patients with temporomandibular TMJ joint pain of at least 3 months duration who have mouth opening limitation and moderate to severe joint pain made worse by joint movement may be eligible for this study Patients must not have any TMJ growth disturbances and must not have had any TMJ surgery for 6 months before entering the study Candidates are screened with questionnaires a medical history and a physical examination of the TMJs including x-rays and magnetic resonance imaging
Participants are randomly assigned to receive three injections each a week apart of either Synvisc or placebo a salt-water solution into the affected joint Before the first injection a sample of synovial fluid is collected from the joint by needle aspiration for laboratory analysis Patients return for follow-up visits 3 6 and 12 months after the last treatment for a clinical examination of the jaw joint and review of jaw joint symptoms A second aspiration is requested at the 3-month visit but is not mandatory All injections and aspirations are done after anesthetizing the overlying skin and joint capsule to minimize pain or discomfort Participants record their daily use of pain relief medication throughout the study
Patients with temporomandibular TMJ joint pain of at least 3 months duration who have mouth opening limitation and moderate to severe joint pain made worse by joint movement may be eligible for this study Patients must not have any TMJ growth disturbances and must not have had any TMJ surgery for 6 months before entering the study Candidates are screened with questionnaires a medical history and a physical examination of the TMJs including x-rays and magnetic resonance imaging
Participants are randomly assigned to receive three injections each a week apart of either Synvisc or placebo a salt-water solution into the affected joint Before the first injection a sample of synovial fluid is collected from the joint by needle aspiration for laboratory analysis Patients return for follow-up visits 3 6 and 12 months after the last treatment for a clinical examination of the jaw joint and review of jaw joint symptoms A second aspiration is requested at the 3-month visit but is not mandatory All injections and aspirations are done after anesthetizing the overlying skin and joint capsule to minimize pain or discomfort Participants record their daily use of pain relief medication throughout the study
Detailed Description:
The proposed clinical trial will evaluate the effects of high molecular weight hylan Synvisc injection in comparison with control treatment saline injection for osteoarthritis OA affecting the temporomandibular joint TMJ Patients with TMJ OA of at least three-month duration and who have not responded to conservative treatments will be included Patients will be randomly assigned to either high molecular hylan injection or control At baseline and follow up visits clinical outcome measures will be assessed such as pain and range of motion Positive findings in clinical outcome measures will provide evidence for the clinical utility of Synvisc in patients with painful TMJ OA In addition to clinical outcome measures a sample of synovial fluid from the affected joint will be obtained at the baseline visit and at 12 week follow up and levels of tumor necrosis factor alpha TNF alpha Matrix metalloproteinase MMP and Tissue inhibitor of metalloproteinase TIMP will be analyzed By studying the synovial fluid levels of TNF alpha MMP and TIMP we will assess the effects of viscosupplementation with Synvisc on the local inflammatory process and proteolytic activity in TMJ OA in comparison with control treatment Positive findings in clinical symptoms and synovial fluid analysis will also provide implications of clinical utility of Synvisc in patients with painful TMJ OA Furthermore this analysis of synovial fluid may identify biomarkers associated with OA affecting the TMJ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-D-0111 | None | None | None |