Study Stopped
The study was terminated due to poor enrollment
Effectiveness of a Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis
Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis
1 other identifier
interventional
11
1 country
1
Brief Summary
Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Dec 2011
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 23, 2013
July 1, 2013
1.6 years
November 21, 2011
July 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in knee pain
The primary outcome measure will be a reduction in knee pain as measured by the VAS pain score. The secondary outcome measure will be an increase in function as measured by the WOMAC Osteoarthritis Questionnaire.
3 months
Study Arms (3)
Viscosupplementation injections
OTHERControl group will receive a series of three viscosupplementation injections into the affected knee
Off-loading knee brace
EXPERIMENTALViscosupplementation and knee brace
EXPERIMENTALInterventions
Subjects will receive a series of three Orthovisc injections into their affected knee
Subjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee
Subjects will receive a series of three Orthovisc injections and be fitted and educated on using a DonJoy HA lite knee brace
Eligibility Criteria
You may qualify if:
- Subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is confirmed by radiographs.
- Radiographs will be obtained and patients with mild to moderate knee osteoarthritis will qualify a subject for enrollment.
- Subjects will also have a documented varus deformity.
You may not qualify if:
- Subjects with severe arthritis as demonstrated by radiographs.
- In addition those subjects with a known or suspected joint infection and subjects who had undergone arthrocentesis and/or intra-articular injection within 3 months of the study will be excluded.
- Female patients who are pregnant or breast feeding will also be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OAD Orthopaedicslead
Study Sites (1)
OAD Orthopaedics
Warrenville, Illinois, 60555, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William R Sterba, MD
OAD Orthopaedics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2011
First Posted
November 23, 2011
Study Start
December 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 23, 2013
Record last verified: 2013-07