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

NCT ID: NCT01210183

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-12-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Dextrose intraarticularly administered

9 ml of 12.5% dextrose

Intervention Type: DRUG

Other Intervention Names

Glucose

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Nacional de Rosario

OTHER

Sponsor Role: lead

Responsible Party

Gastón Andrés Topol

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaston A Topol, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Provincial de Rosario

Locations

Hospital Provincial de Rosario

Rosario, Santa Fe Province, Argentina

Countries

Argentina

References

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.

Reference Type: DERIVED

PMID: 27058744 (View on PubMed)

Other Identifiers

ProvingCartilageGrowth

Identifier Type: -

Identifier Source: org_study_id