Effects of Knee Injections on Patients With Knee Osteoarthritis

NCT05220527 | Unknown Phase 4

• 1 other identifier: MOST109-2314-B-341-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability and Health.

Conditions

Knee Osteoarthritis; Injection; Effect of Drug

Keywords

knee osteoarthritis; steroid; hyaluronic acid; dextrose

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis index

  assess knee related performance, scores: 0-100, higher score indicates a worse outcome

  changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

Secondary Outcomes (5)

• physical functional performance-walking

  changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

• physical functional performance-stairs climbing

  changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

• physical functional performance-chair rising

  changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

• physical functional performance-balance

  changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

• Knee Injury and Osteoarthritis Outcome Score

  changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

Study Arms (3)

Study group

EXPERIMENTAL

triamcinolone plus hyruan injection

Drug: Triamcinolone plus hyruan

Experimental

ACTIVE COMPARATOR

vitagen plus hyruan injection

Drug: vitagen plus hyruan

Placebo

PLACEBO COMPARATOR

normal saline plus hyruan injection

Drug: normal saline plus hyruan

Interventions

Triamcinolone plus hyruan DRUG

triamcinolone plus hyruan injections, one time per week, for 3 weeks

Also known as: corticosteroids plus hyaluronic acid

Study group

vitagen plus hyruan DRUG

vitagen plus hyruan injections, one time per week, for 3 weeks

Also known as: dextrose plus hyaluronic acid

Experimental

normal saline plus hyruan DRUG

normal saline plus hyruan injections, one time per week, for 3 weeks

Also known as: normal saline plus hyaluronic acid

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of knee osteoarthritis
• can walk for 15 meters
• Kellgren-Lawrence grade 2 or greater
• can follow up for 6 months

You may not qualify if:

• Major diseases will affect balance, such as stroke
• infectious disease,
• rheumatoid arthritis,
• malignancy
• pregnancy or prepare to pregnant
• received knee injections in the past 6 months
• previous knee operation history

Sponsors & Collaborators

• Taipei Medical University: lead
• Shin Kong Wu Ho-Su Memorial Hospital: collaborator

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Triamcinolone; Adrenal Cortex Hormones; Hyaluronic Acid; Glucose; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glycosaminoglycans; Polysaccharides; Carbohydrates; Hexoses; Monosaccharides; Sugars; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ru-Lan Hsieh, MD

  Shin Kong Wu Ho-Su Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 2, 2022
• Study Start: August 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available after publication and for one year since publication.
• Access Criteria: Request by mail to the investigator.

Locations

TW (1)