Clinical trial NCT01210183: Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose
Official title: Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose Injections Without Weight Bearing Restriction: A Double Arthroscopic Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Knee Osteoarthritis
Keywords: Dextrose
Cartilage
Regeneration
Lead sponsor: Universidad Nacional de Rosario
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 monitored by pre and post treatment arthroscopy views with specialized (methylene blue) staining for cartilage.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Quality of cartilage growth
timeFrame: 0 to 3 months
measure: Number of sections of medial condyle with loss, no change or growth of cartilage.
timeFrame: 7.5 month mean
Secondary outcomes:
measure: Walking pain
timeFrame: 0 to 3 years
measure: Flexion range of motion
timeFrame: 0 to 3 months
measure: WOMAC
timeFrame: 7.5 Months
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Hospital Provincial de Rosario
state: Santa Fe
Study officials:
affiliation: Hospital Provincial de Rosario
name: Gaston A Topol, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.