Hospital Provincial de Rosario
Rosario, Santa Fe Province, Argentina
NCT Number: NCT01210183
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.
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Notify Me40 year and older
All sexes
Interventional
Phase 2 / Phase 3
Rosario, Santa Fe Province, Argentina
Historical, compliance, examination,anesthetic injection, radiographic and arthroscopic screening will be completed. One month after arthroscopy completion, the intervention phase will begin.
INTERVENTION
SECOND ARTHROSCOPY TIMING
METHOD OF ARTHROSCOPY
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
9 ml of 12.5% dextrose
Other names: Glucose
Time frame: 0 to 3 months
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: 7.5 month mean
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: 0 to 3 years
Subjects will be asked to estimate their walking pain on a 10 point scale over the preceding 2 weeks.
Time frame: 0 to 3 months
The total flexion range of motion of the knee will be measured goniometrically.
Time frame: 7.5 Months
WOMAC will be administered at time 0 and at time of the 2nd arthroscopy.
Universidad Nacional de Rosario
Other
Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose Injections Without Weight Bearing Restriction: A Double Arthroscopic Assessment
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