The Knee Usual Care Evaluation Study



Status:Terminated
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:30 - 80
Updated:12/3/2017
Start Date:July 2013
End Date:March 21, 2014

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Title: The Study of Intra-articular Interventions of Platelet Rich Plasma or Hyaluronic Acid Compounds vs. Usual Care (Exercise/Diet/Supplements) in the Medical Management of Knee OA- Effects on Pain and Function; Effects on Articular Cartilage; Effects on Time to Partial or Total Knee Arthroplasty: The Knee Usual Care Evaluation (KUCE) Study

The purpose of this prospective data collection is to track patients who are treated at HSS
who are confirmed with knee osteoarthritis. The registry will collect prospective patient
related and functional outcomes (including use of assistive devices), medication use and
imaging data on patients with confirmed osteoarthritis, and the effect of different medical
interventions that include PRP, Synvisc / Orthovisc /Euflexxa, bracing, suggested exercises,
supplements, and diet. Information from the data collection will be used to compare outcomes
of non-surgical alternatives with the end point being knee arthroplasty. The information
results will enhance our knowledge of the long-term efficacy and effectiveness of
non-surgical interventions intended to treat the progression of osteoarthritis.

Hypotheses:

- Different non-surgical interventions such as PRP, Synvisc®, Orthrovisc®, Euflexxa,
bracing, physical therapy, and a prescribed combination of exercise, diet, and
supplements will demonstrate statistically significant differences in patient pain and
functional outcomes compared to usual interventions including use of NSAIDs,
corticosteroid injections, and use of assistive devices such as canes.

- Non-operative interventions for knee osteoarthritis will be associated with different
rates of breakdown of articular cartilage and different rates of progression of
osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?

- Education about available non-operative treatment methods may change time the end point
of total or partial knee replacement for patients with knee osteoarthritis of varying
severity.

- Different non-operative interventions will be associated with different times to total
or partial knee arthroplasty in patient with knee osteoarthritis of similar severity.

- An electronic data capture system (EDC) for osteoarthritis patients will improve patient
care and patient outcomes.

Specific Aims:

- To ascertain the long term success of non-surgical interventions intended to alleviate
symptoms or slow progression of osteoarthritis of the knee.

- To ascertain if non-operative interventions for knee osteoarthritis improve patient
pain, function, and quality of life.

- To ascertain if non-operative interventions for knee osteoarthritis affect the breakdown
of articular cartilage and slow progression of osteoarthritis as evidenced by MRI or
joint space narrowing on standing knee films?

- To ascertain the amount of time between the initial entry into care at HSS and the end
point of total or partial knee replacement for patients with knee osteoarthritis of
varying severity.

- To ascertain if non-operative interventions for knee osteoarthritis prolong time to knee
replacement surgery.

- To implement at electronic data capture system (EDC) for osteoarthritis patients which
will store validated patient reported outcomes, physical findings, and imaging results.

Inclusion Criteria:

- Age greater than 30 years and less than 80 years

- Knee pain for at least 6 weeks

- Pain rate greater than or equal to 4/10 on a visual analog scale

- Morning stiffness less than 30 minutes

- Crepitus on active motion of the knee, bony tenderness, or bony enlargement of the
knee

- Willing and able to consider all medical treatment options used to manage
osteoarthritis of the knee

- No contraindications to knee radiographs or MRI

- Willing to participate in a registry

- Able to understand and sign a consent

- Able to answer registry questions independently

Exclusion Criteria:

- Diagnosis of a systemic rheumatic disease or crystalline arthritis (ie RA, SLE,
systemic sclerosis, psoriatic arthritis or psoriasis, gout, pseudogout, lyme
arthritis, reactive arthritis, viral arthritis

- pregnant or nursing

- unable to give informed consent

- contraindication to MRI such as indwelling paemaker or cochlear implant

- requirement of metal equipment (such as oxygen)

- known claustrophobia

- gadolinium allergy

- lack of fluency in English. Unfortunately, we do not have the financial resources to
offer full translation services
We found this trial at
1
site
535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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mi
from
New York, NY
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