NCT02280538

Brief Summary

The present study is designed to test the hypothesis that Intra-Articular Hyaluronic Acid (IAHA) is superior to placebo in slowing structural progression and on long term symptomatic effect in primary knee Osteoarthritis (OA) patients. The investigators will perform a multicenter double-blind, randomized, placebo-controlled, parallel group trial.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

3.8 years

First QC Date

October 29, 2014

Last Update Submit

October 31, 2014

Conditions

Osteoarthritis Of Knee

Keywords

Knee OsteoarthritisIntra-Articular Hyaluronic Aciddisease modifying

Outcome Measures

Primary Outcomes (1)

  • Joint Space Width

    Mean change of minimal JSW of the most affected compartment of the tibiofemural joint in both placebo and IAHA groups at the end of follow-up (2 years).

    2 years

Secondary Outcomes (11)

  • OMERACT/OARSI 2004 response

    6 months

  • OMERACT/OARSI 2004 response

    2 years

  • Ocurrence of Knee replacement surgery

    2 years

  • Acetaminophen Consumption

    2 years

  • NSAIDs

    2 years

  • +6 more secondary outcomes

Study Arms (2)

Intra-Articular Hyaluronic Acid

EXPERIMENTAL

hylan G-F 20 (high molecular weight hyaluronic acid): * intra-articular administration * 6 mL * administered every 6 months * for 2 years

Device: Intra-Articular Hyaluronic Acid

Placebo

PLACEBO COMPARATOR

Saline solution: * intra-articular administration * 6 mL * administered every 6 months * for 2 years

Device: Placebo

Interventions

Intra-Articular Hyaluronic AcidDEVICE
Also known as: hylan GF-20
Intra-Articular Hyaluronic Acid
PlaceboDEVICE
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic knee OA as defined by the ACR clinical and radiographic criteria
  • Kellgren-Lawrence grade of II or III on prior x-rays (taken within 6 months of the screen visit) or screen X-ray
  • A minimum medial and/or lateral JSW of the target knee of 2 mm
  • Oral corticosteroids (≤10 mg/day prednisolone or equivalent), NSAIDs, and acetaminophen are permitted if the dose had been stable for at least one month prior to baseline

You may not qualify if:

  • Body mass index greater than 40 kg/m2
  • Varus or valgus deformity of the knee \> 15 degrees (assessed by goniometry)
  • History of trauma, surgery or planned surgery to the study joint (including arthroscopy surgery), joint inflammatory diseases, septic arthritis and/or microcrystalline arthropathies
  • Coagulation/platelet disorders
  • Active malignancy, active systemic infection, or any contraindication to MRI
  • Potent analgesics including opiates, oral corticosteroid therapy within one month prior to enrolment into the study other than stable doses of ≤ 10 mg daily prednisolone or equivalent
  • Knee administration of intra-articular steroids in the previous 3 months or HA injections during the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz

Lisbon, Lisbon District, Portugal

RECRUITING

Centro Hospitalar Lisboa Norte

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jaime C Branco, MD, PhD

    CEDOC

    PRINCIPAL INVESTIGATOR

  • Alexandre Sepriano, MD

    Centro Hospitalar de Lisboa Ocidental

    STUDY DIRECTOR

  • João Gomes, MD

    Centro Hospitalar de Lisboa Ocidental

    STUDY CHAIR

Central Study Contacts

Alexandre Sepriano, MD

CONTACT

alexsepriano@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

PT(2)