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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
SECOND ARTHROSCOPY TIMING
METHOD OF ARTHROSCOPY
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextrose intraarticularly administered | Drug | 9 ml of 12.5% dextrose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Walking pain | Subjects will be asked to estimate their walking pain on a 10 point scale over the preceding 2 weeks. | 0 to 3 years |
| Flexion range of motion | The total flexion range of motion of the knee will be measured goniometrically. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaston A Topol, M.D. | Hospital Provincial de Rosario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Provincial de Rosario | Rosario | Santa Fe Province | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27058744 | Derived | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| 0 to 3 months |
| WOMAC | WOMAC will be administered at time 0 and at time of the 2nd arthroscopy. | 7.5 Months |
| D012216 |
| Rheumatic Diseases |