The Knee Usual Care Evaluation Study | NCT01905358

Studies
The Knee Usual Care Evaluation Study

NCT01905358

Sponsor

Hospital for Special Surgery, New York

Status

Terminated

Last Update Posted

Dec 2, 2017Actual

Enrollment

906Actual

Phase

Not provided

Conditions

Knee Osteoarthritis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Mar 21, 2014Actual

Completion Date

Mar 21, 2014Actual

First Submitted Date

Jul 16, 2013

First Submission Date that Met QC Criteria

Jul 19, 2013

First Posted Date

Jul 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2017

Last Update Posted Date

Dec 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

906Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Whole-Organ MRI Scoring (WORMS)	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.

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Hospital for Special Surgery knee osteoarthritis patients

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Hospital for Special Surgery		New York	New York	10021	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12801417	Background	Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.
14972335	Background	Peterfy CG, Guermazi A, Zaim S, Tirman PF, Miaux Y, White D, Kothari M, Lu Y, Fye K, Zhao S, Genant HK. Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis. Osteoarthritis Cartilage. 2004 Mar;12(3):177-90. doi: 10.1016/j.joca.2003.11.003.

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases