Overview

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

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universidad Nacional de Rosario
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.