Knee OsteoarthritisPhase 2/3NCT01210183
Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose
A Phase 2/3 study testing Dextrose intraarticularly administered in people with Knee Osteoarthritis, run by Universidad Nacional de Rosario at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Dextrose intraarticularly administered
- How many people
- 6 participants
- Where
- 1 siteArgentina
- Study dates
- Jul 2010to Dec 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- No dementia.
- No radiating back pain.
- No systemic inflammatory conditions.
- No history of knee fracture or infection.
- No cancer history.
- No blood thinners.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose Injections Without Weight Bearing Restriction: A Double Arthroscopic Assessment
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.
Read the 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
- Being tested
- Dextrose intraarticularly administered
- Keywords
- Dextrose, Cartilage, Regeneration
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose intraarticularly administeredDrug
Also called Glucose
9 ml of 12.5% dextrose
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of cartilage growth
A Jamshidi needle biopsy will be obtained at 45 degrees in the area of maximum cartilage growth and analyzed for quality/type of cartilage if such growth is seen.
Measured: 0 to 3 months
Number of sections of medial condyle with loss, no change or growth of cartilage.
Arthroscopy of all 9 sections of the medial condyle for each of 6 knees will be viewed by each of 3 arthroscopers who will render their opinion for each section. They will compare sections from 1st and 2nd arthroscopy side by side, and will be asked to indicate loss of cartilage no change or growth of cartilage for each of sections on each of 6 knees.
Still photos of the biopsy study site wiThe photo of the Out IV lesion will be analyzed in a blinded fashion for a visual or computerized assessment of the percentage of lesion size covered by cartilage buds.
Measured: 7.5 month mean
Secondary outcomes (3)
Walking pain
Subjects will be asked to estimate their walking pain on a 10 point scale over the preceding 2 weeks.
Measured: 0 to 3 years
Flexion range of motion
The total flexion range of motion of the knee will be measured goniometrically.
Measured: 0 to 3 months
WOMAC
WOMAC will be administered at time 0 and at time of the 2nd arthroscopy.
Measured: 7.5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gastón Andrés Topol, Universidad Nacional de Rosario
- Investigators
- Gaston A Topol, M.D., Principal investigator, Hospital Provincial de Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210183
- Sponsor's protocol ID
- ProvingCartilageGrowth
- Status last verified
- May 2014
- First submitted
- 27 Sep 2010
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27058744
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose Injections Without Weight Bearing Restriction: A Double Arthroscopic Assessment
- ClinicalTrials.gov ID
- NCT01210183
- Acronym / sponsor ID
- ProvingCartilageGrowth
- Conditions
- Knee Osteoarthritis
- Keywords
- Dextrose, Cartilage, Regeneration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universidad Nacional de RosarioUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- No dementia.
- No radiating back pain.
- No systemic inflammatory conditions.
- No history of knee fracture or infection.
- No cancer history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose intraarticularly administeredAlso: Glucose9 ml of 12.5% dextrose | Drug | – |
Primary outcome
Quality of cartilage growth
Time frame: 0 to 3 months
A Jamshidi needle biopsy will be obtained at 45 degrees in the area of maximum cartilage growth and analyzed for quality/type of cartilage if such growth is seen.
Number of sections of medial condyle with loss, no change or growth of cartilage.
Time frame: 7.5 month mean
Arthroscopy of all 9 sections of the medial condyle for each of 6 knees will be viewed by each of 3 arthroscopers who will render their opinion for each section. They will compare sections from 1st and 2nd arthroscopy side by side, and will be asked to indicate loss of cartilage no change or growth of cartilage for each of sections on each of 6 knees. Still photos of the biopsy study site wiThe photo of the Out IV lesion will be analyzed in a blinded fashion for a visual or computerized assessment of the percentage of lesion size covered by cartilage buds.
3 secondary outcomes
Walking pain
Time frame: 0 to 3 years
Flexion range of motion
Time frame: 0 to 3 months
WOMAC
Time frame: 7.5 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Derived from this study: PubMed 27058744Topol 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaston A Topol, M.D. principal investigator
Hospital Provincial de Rosario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dextrose intraarticularly administered in people with Knee Osteoarthritis, run by Universidad Nacional de Rosario at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of cartilage growth (time frame: 0 to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01210183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.