Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147186
Status:
UNKNOWN
Last Update Posted:
2007-01-15
First Post:
2005-09-06
Brief Title:
The Effectiveness of Hylan GF-20 on Joint Reaction Forces and Kinematic Patterns During Gait in Patients With Knee Osteoarthritis
Sponsor:
Kessler Foundation
Organization:
Kessler Foundation
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The use of Hylan G-F 20 as a treatment of osteoarthritis OA of the knee has become popular in recent years Typical treatment of OA of the knee includes NSAIDs and physical therapy protocols to strengthen local muscle groups and decrease pain When these conservative treatment modalities have been exhausted the next step is arthroplasty of the knee Hylan G-F 20 treatments provide physicians with an intermediate mode of treatment prior to surgery Hylan G-F 20 is a cross-linked high molecular weight derivative of hyaluronan which can be found within the synovial capsule of the knee This form of viscosupplementation is intended to reduce the pain suffered by those with OA by increasing the fluid levels within the synovial space providing a cushion between the bony surfaces within the knee joint Current studies have only looked at self-reported pain relief or Outcomes Inventories This study aims to determine the ability of Hylan G-F 20 treatment to improve the parameters of gait of individuals who suffer from OA
Detailed Description:
Typically when an adult suffers from OA of the knee they are presented with two choices conservative treatments consisting of NSAID therapy and physical therapy or surgical intervention to replace the affected knee joint There is a third avenue of treatment that has become available in recent years This treatment modality is viscosupplementation Viscosupplementation consists of replacing hyaluronic acid in the synovial fluid contained in the knee joint It has been observed that the synovial fluid of OA sufferers has less hyaluronic acid HA and the HA that remains is of lower molecular size and concentration Replacement of the HA contained in the synovial fluid through the use of Hylan G-F 20 has been shown in clinical studies to be clinically safe and have the ability to provide pain relief with a minimum of adverse reactions Clinical studies concerning the use of Hylan G-F 20 have focused on safety and efficacy in regards to pain relief in those who suffer OA To date there have been few studies performed looking at the efficacy of Hylan G-F 20 on the kinematics and kinetics of gait This study will provide data on the ability of Hylan G-F 20 treatment to improve the temporal-spatial parameters of gait in those who suffer OA as well as the ability of Hylan G-F 20 to reduce joint reaction forces in the affected knee
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