Trial | NCT01210183  Report issue

Title

Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose
Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose Injections Without Weight Bearing Restriction: A Double Arthroscopic Assessment

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    6
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.
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.
Study Started
Jul 31
2010
Primary Completion
Dec 31
2013
Study Completion
Dec 31
2013
Last Update
May 20
2014
Estimate

Drug Dextrose intraarticularly administered

9 ml of 12.5% dextrose

  • Other names: Glucose

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.
No Results Posted