NCT02197026

Brief Summary

Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
518

participants targeted

Target at P75+ for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2000

Completed
14.5 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

July 18, 2014

Last Update Submit

July 21, 2014

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Cost of knee OA treatment including cost of side effect related to OA treatment

    up to 274 days

  • Area under the curve (AUC) Lequesne index

    Index of severity

    Day 1, 29, 91, 182 and 274

Secondary Outcomes (9)

  • Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient

    Day 1, 91, 182 and 274

  • Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3

    Day 1, 91, 182 and 274

  • Disease activity assessment by patient and investigator on a VAS

    Day 1, 29, 91, 182 and 274

  • Acute congestive OA flares assessed through a questionnaire

    Day 1, 29, 91, 182 and 274

  • Assessment of state of health of the patients with a quality of life questionnaire (SF 12)

    Day 1, 91, 182, 274

  • +4 more secondary outcomes

Study Arms (2)

Synvisc group

EXPERIMENTAL

injection of Synvisc® at day 1, day 8 and day 15; in the mean time it will be recommended to decrease or stop all other OA treatments

Drug: Hylan G-F 20

Osteoarthritis standard treatment group

ACTIVE COMPARATOR

Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product

Drug: Standard treatmentProcedure: PhysiotherapyProcedure: Hydrotherapy

Interventions

Hylan G-F 20DRUG
Also known as: Synvisc®
Synvisc group
Standard treatmentDRUG

Standard drug treatment at the discretion of the investigator

Osteoarthritis standard treatment group
PhysiotherapyPROCEDURE
Osteoarthritis standard treatment group
HydrotherapyPROCEDURE
Osteoarthritis standard treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female outpatient aged at least 18 years
  • Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. The diagnosis must be based on American College of Rheumatology (ACR) criteria. Radiological grade will be assess according to Kellgren-Lawrence scale
  • Assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm VAS
  • Patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs
  • Patient's informed written consent obtained in accordance with French legislation

You may not qualify if:

  • nocturnal disturbances due to knee pain
  • morning stiffness over 45 minutes
  • increase of knee pain more than 50% within the last week
  • articular reddening
  • articular heat
  • Intra-articular administration of hyaluronic acid in the target knee within the previous year
  • Intra-articular administration of hyaluronic acid in the target knee within the three previous months
  • Any other intra-articular injection in the target knee within the last 6 months
  • Any contraindication to intra-articular injections
  • Present or past history of infected target knee joint
  • Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of the target knee
  • Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the previous year
  • Planned knee surgery within the nine following month
  • Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis or the evaluation of its severity
  • Known hypersensitivity to avian products
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

hylanPhysical Therapy ModalitiesHydrotherapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2014

First Posted

July 22, 2014

Study Start

October 1, 1998

Primary Completion

February 1, 2000

Last Updated

July 22, 2014

Record last verified: 2014-07