Cartilage InjuryPhase 1/2NCT01442571
Hyaluronic Acid Injection Post Arthroscopy - Does it Improve Immediate Function? Double Blind Controlled Prospective Study
A Phase 1/2 study testing Hyaluronic Acid Injection and Saline Injection in people with Cartilage Injury, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The proposed research is to examine the effect of injecting a large volume of HA (10cc) at the time of post arthroscopy suture removal (9-11 day post surgery), in patients with cartilage damage of ICRS grade 2 and above in one of the knee compartments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cartilage Injury
- What is being tested?
- Hyaluronic Acid Injection and Saline Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher in one of the compartments (in addition to other injuries such as meniscal tear and cruciate ligament).
Who cannot join
- Patients with known rheumatic disorders.
- Known hypersensitivity to HA.
- Synovial diseases like PVNS, under 18y old.
Trial locations and contacts
1 site in 1 country.
About this study
The proposed research is to examine the effect of injecting a large volume of HA (10cc) at the time of post arthroscopy suture removal (9-11 day post surgery), in patients with cartilage damage of ICRS grade 2 and above in one of the knee compartments.
- Conditions
- Cartilage Injury
- Being tested
- Hyaluronic Acid Injection, Saline Injection
- Keywords
- Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid InjectionDevice
Saline InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid Injection, pain, function | Experimental | Not described Receives: Device: Hyaluronic Acid Injection |
| Saline Injection | Placebo comparator | Not described Receives: Drug: Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC (the International Knee Documentation Committee)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage InjuryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442571
- Sponsor's protocol ID
- sports01-CTIL-HMO
- Status last verified
- Aug 2011
- First submitted
- 4 Sep 2011
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid Injection Post Arthroscopy - Does it Improve Immediate Function? Double Blind Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT01442571
- Acronym / sponsor ID
- sports01-CTIL-HMO
- Conditions
- Cartilage Injury
- Keywords
- Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 28 Sep 2011 (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.
The proposed research is to examine the effect of injecting a large volume of HA (10cc) at the time of post arthroscopy suture removal (9-11 day post surgery), in patients with cartilage damage of ICRS grade 2 and above in one of the knee compartments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid Injection, pain, function | Experimental | Device: Hyaluronic Acid Injection |
| Saline Injection | Placebo comparator | Drug: Saline Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher in one of the compartments (in addition to other injuries such as meniscal tear and cruciate ligament).
Key exclusion criteria (3 listed)
- Patients with known rheumatic disorders.
- Known hypersensitivity to HA.
- Synovial diseases like PVNS, under 18y old.
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 |
|---|---|---|
| Hyaluronic Acid Injection | Device | Hyaluronic Acid Injection, pain, function |
| Saline Injection | Drug | Saline Injection |
Primary outcome
IKDC (the International Knee Documentation Committee)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyaluronic Acid Injection and Saline Injection in people with Cartilage Injury, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 2011. 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 Israel. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadas Lemberg, PhD (00 972 2 6777572, lhadas@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKDC (the International Knee Documentation Committee). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2011.