Overview
Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose
Status:
Completed
Completed
Trial end date:
2013-12-01
2013-12-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
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.