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

Knee Osteoarthritis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT01210183
• Study type: Interventional
• Source: Universidad Nacional de Rosario
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2010
• Completion date: December 2013