The Knee Usual Care Evaluation Study (KUCE)

November 29, 2017 updated by: Hospital for Special Surgery, New York

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

906

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital for Special Surgery knee osteoarthritis patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form (12) Health Survey (SF-12)
Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
Change is being assessed.
6 months, 12 months, 24 months, 36 months, 48 months and 60 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
Change is being assessed.
6 months, 12 months, 24 months, 36 months, 48 months and 60 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole-Organ MRI Scoring (WORMS)
Time Frame: baseline, 1 year, 2 years, 5 years
Changes in MRI will be measured by a chance in the Whole-Organ MRI Scoring (WORMS) score of femur and tibia, and Outerbridge score for cartilage. The Boston Osteoarthritis Knee Study defined cartilage loss using the WORMS score as "an increase in the score at any sub-region compared to baseline in any of the 14 subregions of the knee scored for cartilage in each knee." For patients who have only standing radiographs available a 0.7 mm loss of joint space will be considered a significant loss over 3 years. Bruyere et al predicted that "the cut off for minimum JSN maximizing sensitivity and specificity for predicting future surgery was a change of 0.7 mm or more in minimum joint space width over a period of three years." Note: change is being assessed.
baseline, 1 year, 2 years, 5 years
X-ray with Kellgren-Lawrence Grading
Time Frame: baseline, 4 years
Change is being assessed.
baseline, 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 21, 2014

Study Completion (Actual)

March 21, 2014

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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