NCT02671565

Brief Summary

Osteoarthritis (OA) is a degenerative joint disease in which there is an imbalance between the breakdown and repair of the joint tissue. Intraarticular hyaluronic acid (HA) injections are used for the management of knee OA. Currently, there is limited and inconclusive evidence supporting use of HA injections for management of knee OA. The primary objective of our study is to evaluate the effectiveness of HA injections in the management of knee OA. Investigators will evaluate if HA injections prevent or delay knee OA surgical interventions.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,849

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Status
completed

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

January 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

January 20, 2016

Last Update Submit

August 4, 2021

Conditions

Knee Osteoarthritis

Keywords

Intraarticular hyaluronic acid injectionsTotal knee replacementObservational studyIntraarticular corticosteroid injectionsComparative effectiveness

Outcome Measures

Primary Outcomes (1)

  • Number of patients with any knee surgical intervention assessed using the inpatient and outpatient claims in the follow up time

    Each patient will be followed after index date + 90days until the date of his/her first arthroscopic procedure, osteotomy, placement of a free-floating interpositional device, partial or total knee replacement, the study end date, or until the subject is no longer enrolled. The number of events and follow up time will be used to calculate hazard ratios in order to assess the risk of surgical intervention for each comparison

    Person follow up time between 2006-2015

Secondary Outcomes (2)

  • Number of patients with total or partial knee replacement assessed using the inpatient and outpatient claims in the follow up time

    Person follow up time between 2006-2015

  • Number of patients with total knee replacement assessed using the inpatient and outpatient claims in the follow up time

    Person follow up time between 2006-2015

Study Arms (3)

Hyaluronic acid (HA) injection users

Patients with at least one procedure claim for intra-articular administration of hyaluronic acid (procedure codes: J7320, J7322, J7325, Q4084, J7317, Q4083, J7321, Q4085, J7323, Q4086, J7324, J7327, J7326) within 90 days after their first specialist (physical medicine, physical therapy, orthopedic surgeon, rheumatologist or orthopedic) visit will be considered as HA users.

Drug: Hyaluronic Acid injections

Corticosteroids (CS) injections users

Patients with at least one procedure claim for intra-articular administration of corticosteroids (procedure codes: J1020, J1030, J1040, J1094, J1100, J2920, J2930, J0702, J0704, J3300, J3301, J3302, J3303, J1700, J1710, J1720, J2650, J2920, J2930) within 90 days after their first specialist (physical medicine, physical therapy, orthopedic surgeon, rheumatologist or orthopedic) visit will be considered as CS users.

HA non-users

Patients who do not have any claims for procedural or surgical intervention including HA and CS injections in first 90 days after their first specialist visit will be considered as HA non-users

Interventions

Hyaluronic Acid injectionsDRUG
Also known as: Synvisc, Orthovisc, Euflexxa, Monovisc, Hyglan or Supartz
Hyaluronic acid (HA) injection users

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a moderate to severe knee OA identified by using a specialist visit along with recent history of pain medication use (proxy for moderate to severe pain)

You may qualify if:

  • Patients with a specialist visit (orthopedic surgeon, physical medicine and rehabilitation, orthopedic, physical therapy, and rheumatologist) will enter in cohort and the date of the first visit will be considered as index date.
  • Patients should have at least one claim with a primary diagnosis of knee osteoarthritis (ICD-9-Center for Medicare (CM) code 715.x6) on the index date
  • Patients with a specialist visit should have at least one claim for pain medications (NSAIDs or opioids) within 90 days prior to or on the day of visit.
  • The age of a patient should be at least 40 years on the date of their index date
  • Patients to have continuous eligibility for pharmacy and medical benefits for at least six months prior to their index diagnosis.
  • Patients to have at least three months of continuous eligibility for pharmacy and medical benefits after their index diagnosis.

You may not qualify if:

  • Patients with a procedure claim for HA or CS in the pre-index period
  • Patients with a procedure claim for knee OA surgical procedures (arthroscopic procedures, osteotomy, free-floating interpositional devices, partial and total knee replacement) in the pre-index period.
  • In order to focus on knee OA pain, patients with a claim for joint fusion, rheumatoid arthritis, knee fracture, post-traumatic arthritis, avascular necrosis, benign/malignant bone tumors and Paget's disease in the pre-index period will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. Br Med Bull. 2013;105:185-99. doi: 10.1093/bmb/lds038. Epub 2013 Jan 20.

    PMID: 23337796BACKGROUND

  • Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.

    PMID: 22563589BACKGROUND

  • Arrich J, Piribauer F, Mad P, Schmid D, Klaushofer K, Mullner M. Intra-articular hyaluronic acid for the treatment of osteoarthritis of the knee: systematic review and meta-analysis. CMAJ. 2005 Apr 12;172(8):1039-43. doi: 10.1503/cmaj.1041203.

    PMID: 15824412BACKGROUND

  • Medina JM, Thomas A, Denegar CR. Knee osteoarthritis: should your patient opt for hyaluronic acid injection? J Fam Pract. 2006 Aug;55(8):669-75. No abstract available.

    PMID: 16882439BACKGROUND

  • Bannuru RR, Natov NS, Obadan IE, Price LL, Schmid CH, McAlindon TE. Therapeutic trajectory of hyaluronic acid versus corticosteroids in the treatment of knee osteoarthritis: a systematic review and meta-analysis. Arthritis Rheum. 2009 Dec 15;61(12):1704-11. doi: 10.1002/art.24925.

    PMID: 19950318BACKGROUND

  • Lo GH, LaValley M, McAlindon T, Felson DT. Intra-articular hyaluronic acid in treatment of knee osteoarthritis: a meta-analysis. JAMA. 2003 Dec 17;290(23):3115-21. doi: 10.1001/jama.290.23.3115.

    PMID: 14679274BACKGROUND

  • Wang CT, Lin J, Chang CJ, Lin YT, Hou SM. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. A meta-analysis of randomized controlled trials. J Bone Joint Surg Am. 2004 Mar;86(3):538-45. doi: 10.2106/00004623-200403000-00012.

    PMID: 14996880BACKGROUND

  • Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Intraarticular corticosteroid for treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005328. doi: 10.1002/14651858.CD005328.pub2.

    PMID: 16625636BACKGROUND

  • Printz JO, Lee JJ, Knesek M, Urquhart AG. Conflict of interest in the assessment of hyaluronic acid injections for osteoarthritis of the knee: an updated systematic review. J Arthroplasty. 2013 Sep;28(8 Suppl):30-33.e1. doi: 10.1016/j.arth.2013.05.034. Epub 2013 Jul 24.

    PMID: 23890521BACKGROUND

  • Bannuru RR, Natov NS, Dasi UR, Schmid CH, McAlindon TE. Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis--meta-analysis. Osteoarthritis Cartilage. 2011 Jun;19(6):611-9. doi: 10.1016/j.joca.2010.09.014. Epub 2011 Apr 9.

    PMID: 21443958BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

hylanorthoviscHyaluronic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Bradley Martin, PharmD, PhD

    University of Arkansas

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

February 2, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 5, 2021

Record last verified: 2016-08