NCT01210183

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2 knee-osteoarthritis

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_2 knee-osteoarthritis

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

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

3.4 years

First QC Date

September 27, 2010

Last Update Submit

May 19, 2014

Conditions

Knee Osteoarthritis

Keywords

DextroseCartilageRegeneration

Outcome Measures

Primary Outcomes (2)

  • 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.

    0 to 3 months

  • 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.

    7.5 month mean

Secondary Outcomes (3)

  • Walking pain

    0 to 3 years

  • Flexion range of motion

    0 to 3 months

  • WOMAC

    7.5 Months

Interventions

Dextrose intraarticularly administeredDRUG

9 ml of 12.5% dextrose

Also known as: Glucose

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • % 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Provincial de Rosario

Rosario, Santa Fe Province, Argentina

Location

Related Publications (1)

  • 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: 27058744DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucose

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Gaston A Topol, M.D.

    Hospital Provincial de Rosario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

AR(1)