Status:
COMPLETED
Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose
Lead Sponsor:
Universidad Nacional de Rosario
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief 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 moni...
Detailed Description
Historical, compliance, examination,anesthetic injection, radiographic and arthroscopic screening will be completed. One month after arthroscopy completion, the intervention phase will begin. INTERVE...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01210183
Start Date
July 1 2010
End Date
December 1 2013
Last Update
May 20 2014
Active Locations (1)
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1
Hospital Provincial de Rosario
Rosario, Santa Fe Province, Argentina