Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-11-23

Brief Summary

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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 For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing.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 Fluid will be withdrawn from the knee at time zero, one week, and three months.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. .

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Detailed Description

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Participants with stage IV knee osteoarthritis will be evaluated for eligibility and randomized 1 to 1 using an Internet randomization method to ensure random allocation.

At time zero all participants will receive aspiration of their knees from the suprapatellar pouch of 5.5 mL of synovial fluid for cytokine analysis. After that 10 of the participants will receive injection of 10 mL of 12.5% dextrose. The other 10 will receive no injection after aspiration. Pain levels will be measured at time zero, 15 minutes, two hours and 48 hours after aspiration with or without injection to gather information about the time course of analgesia.

At one week all participants will receive aspiration of 2.0 mL from the suprapatellar pouch for cytokine analysis, followed by injection of the remaining 10 participants with dextrose 12.5%. Pain levels will be measured at the same time intervals to complete evaluation of dextrose analgesia.

After two weeks injections will be open label with 10 mills of dextrose 12 and have percent injected at one, two, three, four, five, and six months. At the three month. Another 2 mL of synovial fluid will be sent to the laboratory for cytokine analysis.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Masking only of above.

Study Groups

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Dextrose 0. Aspiration 1 week.

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.

Group Type EXPERIMENTAL

Dextrose 0

Intervention Type DRUG

Dextrose injection at time 0

Aspiration 1

Intervention Type DRUG

Aspiration only at week 1

Aspiration 0. Dextrose 1 week.

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.

Group Type EXPERIMENTAL

Aspiration 0

Intervention Type DRUG

Aspiration only at time 0

Dextrose 1

Intervention Type DRUG

Dextrose injection at week 1

Interventions

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Dextrose 0

Dextrose injection at time 0

Intervention Type DRUG

Aspiration 0

Aspiration only at time 0

Intervention Type DRUG

Dextrose 1

Dextrose injection at week 1

Intervention Type DRUG

Aspiration 1

Aspiration only at week 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No