Clinical trial NCT01905358: The Knee Usual Care Evaluation Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 906
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital for Special Surgery knee osteoarthritis patients

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Form (12) Health Survey (SF-12)
timeFrame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
Other outcomes:
measure: Whole-Organ MRI Scoring (WORMS)
timeFrame: baseline, 1 year, 2 years, 5 years
measure: X-ray with Kellgren-Lawrence Grading
timeFrame: baseline, 4 years
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
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