NCT03047096

Brief Summary

The aim of present study is to to investigate whether the combined injection of HA and CS was superior than HA alone in the treatment of knee OA.

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
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

February 5, 2017

Last Update Submit

February 8, 2017

Conditions

OsteoarthritisPain SyndromeIntra-articular Injection

Outcome Measures

Primary Outcomes (1)

  • VAS

    Visual analog scale

    6 months

Secondary Outcomes (2)

  • WOMAC

    6 months

  • Knee flexion motion

    6 months

Study Arms (2)

HA & CS group

EXPERIMENTAL

hyaluronic acid and corticosteroids

Drug: hyaluronic acid and corticosteroids

HA group

EXPERIMENTAL

hyaluronic acid

Drug: hyaluronic acid

Interventions

hyaluronic acidDRUG

intra-Articular injection

Also known as: HA
HA group
hyaluronic acid and corticosteroidsDRUG

intra-Articular injection

Also known as: HA and CS
HA & CS group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • According to radiographic findings, patients who are suffering from knee OA for over 3 months have to be stage II-IV according to the Kellgren-Lawrence (KL) grade by a senior radiologist. The diagnosis of symptomatic knee OA is based on American Rheumatism Association classification criteria for knee osteoarthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

OsteoarthritisSomatoform Disorders

Interventions

Hyaluronic AcidAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Shan-zheng Wang, MD

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shan-zheng Wang, MD

CONTACT

+86 15062274599wang_seu_edu@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant secretory of Orthopaedics department

Study Record Dates

First Submitted

February 5, 2017

First Posted

February 8, 2017

Study Start

February 1, 2017

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)