NCT03400631

Brief Summary

Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining participants will be given dextrose injection at the end of the week. After one week dextrose injections will be given at one, two, three, four, five, and six months. Fluid will be withdrawn from the knee at time zero, one week, and three months. The hypothesis is that dextrose injection will cause a change in proteins in the knee consistent with improved repair signals, along with improving knee pain and function. .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 25, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

3.3 years

First QC Date

October 25, 2017

Last Update Submit

August 10, 2022

Conditions

Osteoarthritis, Knee

Keywords

Cytokine

Outcome Measures

Primary Outcomes (2)

  • Short term change in cytokine levels

    Change in cytokine levels from baseline to 1 week

    Obtained at baseline and 1 week

  • Long term change in cytokine levels

    Change in cytokine levels from baseline to 3 months

    Obtained at baseline and 3 months

Secondary Outcomes (2)

  • Post Injection Short Term Pain Course

    0, 15 minutes, 2 hours, and 48 hours after time 0 and 1 week injections

  • WOMAC score

    Obtained at baseline, 3 and 6 months.

Study Arms (2)

Dextrose 0. Aspiration 1 week.

EXPERIMENTAL

Dextrose injection given at time 0, at 1 week aspiration only, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months.

Drug: Dextrose 0Drug: Aspiration 1

Aspiration 0. Dextrose 1 week.

EXPERIMENTAL

Aspiration only at time 0. Dextrose injection given at 1 week, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months.

Drug: Aspiration 0Drug: Dextrose 1

Interventions

Dextrose 0DRUG

Dextrose injection at time 0

Dextrose 0. Aspiration 1 week.
Aspiration 0DRUG

Aspiration only at time 0

Aspiration 0. Dextrose 1 week.
Dextrose 1DRUG

Dextrose injection at week 1

Aspiration 0. Dextrose 1 week.
Aspiration 1DRUG

Aspiration only at week 1

Dextrose 0. Aspiration 1 week.

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee pain for at least 6 months.
  • Clinically diagnosed knee osteoarthritis.
  • Weight-bearing radiograph consistent with high-grade medial compartment cartilage loss (Kellgren-Lawrence Grading Scale level IV).
  • Confirmation of exposed subchondral bone by high-resolution knee ultrasonography.

You may not qualify if:

  • Anticoagulation therapy.
  • Inflammatory or post-infectious knee arthritis.
  • Systemic inflammatory conditions.
  • Knee flexion of less than 100 degrees.
  • Knee extension of less than 165 degrees.
  • Any Valgus
  • Varus more than 15 degrees.
  • Any knee injection in the past 3 months.
  • BMI more than 40
  • Gross synovial folds on ultrasound
  • Elevation of sed rate, C reactive protein, rheumatoid factor or antinuclear antibody.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaston Topol, M.D.. Private Office

Rosario, Santa Fe Province, CS2000CXP, Argentina

Location

Related Publications (2)

  • Sit RW, Chung VCh, Reeves KD, Rabago D, Chan KK, Chan DC, Wu X, Ho RS, Wong SY. Hypertonic dextrose injections (prolotherapy) in the treatment of symptomatic knee osteoarthritis: A systematic review and meta-analysis. Sci Rep. 2016 May 5;6:25247. doi: 10.1038/srep25247.

    PMID: 27146849BACKGROUND

  • Topol GA, Podesta LA, Reeves KD, Giraldo MM, Johnson LL, Grasso R, Jamin A, Clark T, Rabago D. Chondrogenic Effect of Intra-articular Hypertonic-Dextrose (Prolotherapy) in Severe Knee Osteoarthritis. PM R. 2016 Nov;8(11):1072-1082. doi: 10.1016/j.pmrj.2016.03.008. Epub 2016 Apr 4.

    PMID: 27058744BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Gaston Topol, M.D.

    University of Argentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking only of above.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The first two weeks of this study involve two groups with a crossover at 1 week. From two weeks on, there is a single arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gaston Topol, M.D., Principal Investigator

Study Record Dates

First Submitted

October 25, 2017

First Posted

January 17, 2018

Study Start

August 1, 2018

Primary Completion

November 23, 2021

Study Completion

November 23, 2021

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations

AR(1)