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Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
Dextrose intraarticularly administered
Sponsored by
Universidad Nacional de Rosario
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Dextrose, Cartilage, Regeneration

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Weight ≤ 90 kilos.
  • Available for clinic any day.
  • Agreeable to keep coming if pain stops.
  • More than one phone number.(close relative ok)
  • Willing to wait 6 months prior to considering a TKA.
  • Good strength in arms to help stand.
  • Knee flexion more than 100 degrees.
  • 90% reduction of standing, walking and sitting pain 5 minutes after intraarticular injection of 9 ml of 0.25% dextrose.
  • XRay repeat with camera at knee height confirms bone on bone status in the medial compartment.

Exclusion Criteria:

  • No dementia.
  • No radiating back pain.
  • No systemic inflammatory conditions.
  • No history of knee fracture or infection.
  • No cancer history.
  • No blood thinners.
  • No daily narcotic.
  • No walking limitation from another cause.
  • Repetitive squatting or stair use on job.
  • Inability to use one arm to help come to stand.
  • Painful hip ROM or imitative of patient's pain.
  • Knee extension lacking more than 15 degrees on each side.
  • Any degree of valgus.
  • Varus of 20 degree or more.
  • A painful Baker's cyst.
  • Visible bone shift when walking
  • Meniscal tear seen on arthroscopy that could block motion and needs trimming.
  • Significant loose bodies seen on arthroscopy.
  • Severe synovitis seen on arthroscopy.
  • More than 1 outerbridge lesion in the medial compartment of the femur.

Sites / Locations

  • Hospital Provincial de Rosario

Outcomes

Primary Outcome Measures

Quality of cartilage growth
A Jamshidi needle biopsy will be obtained at 45 degrees in the area of maximum cartilage growth and analyzed for quality/type of cartilage if such growth is seen.
Number of sections of medial condyle with loss, no change or growth of cartilage.
Arthroscopy of all 9 sections of the medial condyle for each of 6 knees will be viewed by each of 3 arthroscopers who will render their opinion for each section. They will compare sections from 1st and 2nd arthroscopy side by side, and will be asked to indicate loss of cartilage no change or growth of cartilage for each of sections on each of 6 knees. Still photos of the biopsy study site wiThe photo of the Out IV lesion will be analyzed in a blinded fashion for a visual or computerized assessment of the percentage of lesion size covered by cartilage buds.

Secondary Outcome Measures

Walking pain
Subjects will be asked to estimate their walking pain on a 10 point scale over the preceding 2 weeks.
Flexion range of motion
The total flexion range of motion of the knee will be measured goniometrically.
WOMAC
WOMAC will be administered at time 0 and at time of the 2nd arthroscopy.

Full Information

First Posted
September 27, 2010
Last Updated
May 19, 2014
Sponsor
Universidad Nacional de Rosario
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1. Study Identification

Unique Protocol Identification Number
NCT01210183
Brief Title
Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose
Official Title
Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose Injections Without Weight Bearing Restriction: A Double Arthroscopic Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional de Rosario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dextrose injection in end-stage knee arthritis will cause growth of cartilage cells in a particular area of complete cartilage loss. Dextrose concentration will be 12.5%. Cartilage status will be monitored by pre and post treatment arthroscopy views with specialized (methylene blue) staining for cartilage.
Detailed Description
Historical, compliance, examination,anesthetic injection, radiographic and arthroscopic screening will be completed. One month after arthroscopy completion, the intervention phase will begin. INTERVENTION Injection of 12.5% dextrose at 0, 1 and 2 months. Stand up without using only the non-injected leg for 3 days after each injection. Avoid running and squatting as feasible. Ensure that the injected knee descends stairs first ascends stairs last for 3 days. May take Acetaminophen. No NSAIDS for 2 days before and 10 days after a treatment. PRN NSAIDs only. No glucosamine or chondroitin should be taken. SECOND ARTHROSCOPY TIMING A minimum of 4 months after first arthroscopy, when schedulable. After a minimum of 3 monthly injections of dextrose 12.5% . METHOD OF ARTHROSCOPY Only the medial compartment will be entered to minimize trauma. Methylene blue will be applied and allowed to remain in knee for 5 minutes prior to flush. A standardized method video scan of the medial femoral compartment will be conducted. At second arthroscopy, the area of heaviest cartilage growth, if any, in the base of the Out-IV lesion will be biopsied with a Jamshidi needle at a 45 degree angle. (Limited by the optics of single port entry ). Biopsy, if taken, will be sent for decortication to enable specimen to be cut, safranin O application to determine proteoglycan production, polarized light to differentiate fibrous from hyaline cartilage, and immunohistologic straining for Type I and Type Ii cartilage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Dextrose, Cartilage, Regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dextrose intraarticularly administered
Other Intervention Name(s)
Glucose
Intervention Description
9 ml of 12.5% dextrose
Primary Outcome Measure Information:
Title
Quality of cartilage growth
Description
A Jamshidi needle biopsy will be obtained at 45 degrees in the area of maximum cartilage growth and analyzed for quality/type of cartilage if such growth is seen.
Time Frame
0 to 3 months
Title
Number of sections of medial condyle with loss, no change or growth of cartilage.
Description
Arthroscopy of all 9 sections of the medial condyle for each of 6 knees will be viewed by each of 3 arthroscopers who will render their opinion for each section. They will compare sections from 1st and 2nd arthroscopy side by side, and will be asked to indicate loss of cartilage no change or growth of cartilage for each of sections on each of 6 knees. Still photos of the biopsy study site wiThe photo of the Out IV lesion will be analyzed in a blinded fashion for a visual or computerized assessment of the percentage of lesion size covered by cartilage buds.
Time Frame
7.5 month mean
Secondary Outcome Measure Information:
Title
Walking pain
Description
Subjects will be asked to estimate their walking pain on a 10 point scale over the preceding 2 weeks.
Time Frame
0 to 3 years
Title
Flexion range of motion
Description
The total flexion range of motion of the knee will be measured goniometrically.
Time Frame
0 to 3 months
Title
WOMAC
Description
WOMAC will be administered at time 0 and at time of the 2nd arthroscopy.
Time Frame
7.5 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Weight ≤ 90 kilos. Available for clinic any day. Agreeable to keep coming if pain stops. More than one phone number.(close relative ok) Willing to wait 6 months prior to considering a TKA. Good strength in arms to help stand. Knee flexion more than 100 degrees. 90% reduction of standing, walking and sitting pain 5 minutes after intraarticular injection of 9 ml of 0.25% dextrose. XRay repeat with camera at knee height confirms bone on bone status in the medial compartment. Exclusion Criteria: No dementia. No radiating back pain. No systemic inflammatory conditions. No history of knee fracture or infection. No cancer history. No blood thinners. No daily narcotic. No walking limitation from another cause. Repetitive squatting or stair use on job. Inability to use one arm to help come to stand. Painful hip ROM or imitative of patient's pain. Knee extension lacking more than 15 degrees on each side. Any degree of valgus. Varus of 20 degree or more. A painful Baker's cyst. Visible bone shift when walking Meniscal tear seen on arthroscopy that could block motion and needs trimming. Significant loose bodies seen on arthroscopy. Severe synovitis seen on arthroscopy. More than 1 outerbridge lesion in the medial compartment of the femur.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaston A Topol, M.D.
Organizational Affiliation
Hospital Provincial de Rosario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Provincial de Rosario
City
Rosario
State/Province
Santa Fe
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
27058744
Citation
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.
Results Reference
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Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose

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