NCT01132677

Brief Summary

Do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 28, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

May 27, 2010

Last Update Submit

May 27, 2010

Conditions

Osteoarthritis, Knee

Keywords

OA of KneeOsteoarthritis of KneeViscosupplementation and OsteoarthritisViscosupplementation and OAHyaluronic AcidCorticosteroid injection versus hyaluronic acidSynvisc One and Knee OAviscosupplementation and knee painknee Pain from OA

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be "pain while walking for approximately 30 minutes on a flat surface today" as reported by the patient on a 100mm unmarked VAS (0 = no pain; 100 = worst pain possible).

    As described in title

    VAS Form will be given at baseline (prior to injection) and then at 1, 3 and 6 weeks, and 3 and 6 months post injection.

Secondary Outcomes (1)

  • Pain at rest or with stairs as reported byu the patient on a VAS

    Baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection

Study Arms (2)

Hyaluronic Acid (HA) Injection

ACTIVE COMPARATOR

Patients allocated to the HA group will receive a single IA injection Hylan G-F 20 Synvisc One™ (1 injection of 6cc's). All injections will be administered as outlined on the company label. Aspiration of the knee will not be performed.

Device: Hylan G-F 20 (Synvisc One)

Corticosteroid Injection

ACTIVE COMPARATOR

Patients allocated to the corticosteroid injection will receive a single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label. Aspiration of the knee will not be performed.

Drug: Methylprednisolone (Corticosteroid)

Interventions

Hylan G-F 20 (Synvisc One)DEVICE

Single IA injection of 6cc's. Injections will be administered as outlined on the company label.

Hyaluronic Acid (HA) Injection
Methylprednisolone (Corticosteroid)DRUG

Single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label.

Corticosteroid Injection

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical
  • years of age (inclusive)
  • Symptomatic OA (1 of the following: pain, stiffness, or swelling)
  • Evidence of grade I, II or III OA on radiographic images according to Kellgren-Lawrence grading scale.

You may not qualify if:

  • Clinical
  • Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy)
  • Intra-articular treatment within the last 3 months
  • Ipsilateral cruciate or collateral ligament injury within past 3 months, or evidence of ligament laxity
  • Inflamed knee or pronounced effusion
  • Allergy to birds, eggs, avian proteins or known HA or corticosteroid
  • Venous or lymphatic stasis
  • Skin condition in the injection area
  • Evidence of infection in the affected joint
  • History of crystalline arthropathy or inflammatory arthritis
  • Pregnant or nursing
  • Third Party, Medical Legal or Workers' Compensation Board
  • Patient unable to understand English or unable to providing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LifeMark Health

Kelowna, British Columbia, V1Y 6G2, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

MethylprednisoloneAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Brad J Monteleone, Physician

    UBC - Department of Family Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 28, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

December 1, 2011

Last Updated

May 28, 2010

Record last verified: 2010-02

Locations

CA(1)