ArthralgiaNCT00971074
Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy
A study testing Hylan G-F 20 in people with Arthralgia, run by Grant Jones at 1 site in United States.
Trial summary
The investigators' objective is to analyze a group of patients who have had a partial meniscectomy but continue to have knee pain after surgery with a double-blind, randomized prospective study comparing the use of Hylan G-F 20(single injection of a viscosupplementation) versus placebo injection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Arthralgia
- What is being tested?
- Hylan G-F 20
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2011
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- S/P partial medial and/or lateral partial meniscectomy
- Pre-operative MRI diagnosed meniscal tear
- Diffuse, non-focal arthroscopically diagnosed ICRS Grade II or III chondromalacia. (used to determine the presence of tibiofemoral osteoarthritis)
- Baseline VAS pain score between 50 and 80mm.
- Persistent, generalized knee pain without mechanical symptoms
- Kellgren/Lawrence (K/L) grade II or III (used to determine the presence of tibiofemoral osteoarthritis)
Who cannot join
- Bilateral arthroscopy (within 6 months pre- and post- initial VAS score.
- Complete meniscectomy
- Microfracture (via drilling, picking, abrading, thermal or radiofrequency or any procedure that violates the subchondral plate)
- Focal chondral lesion visualized on arthroscopy or any focal cartilage procedure (e.g. ACI, OATS, mosaicplasty, etc)
- Concomitant ligamentous injury or repair
- K/L stage I or IV
Show all 25Show fewer
- Significant Varus or Valgus clinical malalignment
- S/P tibial osteotomy in target knee
- Isolated patello-femoral OA or isolated anterior knee pain
- Prosthetic implant in either knee
- Re-injury in time between original surgery and baseline visit
- Inflammatory arthritis (e.g. rheumatoid arthritis, gout, pseudogout (chondrocalcinosis), lupus, etc)
- Obesity with BMI > 35 (at time of initial VAS score
- NSAIDs or opiates within one week of baseline randomization or during trial period
- Known allergy to viscosupplements, known allergy to avian, egg or feather products
- Prior Viscosupplementation use in ipsilateral knee
- Oral steroids (within 4 weeks of initial VAS score)
- IA steroids in target knee within 6 months
- Significant medical co-morbidities ( e.g. malignancy, hepatic, renal, cardiac, pulmonary, gastrointestinal disease) in the judgment of the investigator
- Known hip disease
- Pregnant or nursing (at time of injection, pregnancy test at visit)
- Active infection of either lower extremity or past history of septic arthritis
- Venous or lymphatic stasis in either lower extremity
- Enrolled in clinical trial within 3 months of baseline
- Contralateral knee arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Sports Medicine Center
Columbus, Ohio, 43221
About this study
Official title: The Use of Viscosupplementation for the Treatment of Patients With Persistent Non-mechanical Pain Status-post Partial Menisectomy
The investigators' objective is to analyze a group of patients who have had a partial meniscectomy but continue to have knee pain after surgery with a double-blind, randomized prospective study comparing the use of Hylan G-F 20(single injection of a viscosupplementation) versus placebo injection. The investigators would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.
Read the detailed description
A great majority of patients who have a partial menisectomy for mechanical symptoms do well with full return of function without pain. There is a sub-group of patients who are found to have Grade II- III chondromalacia lesions (deemed arthritic) at the time of surgery that have persistent generalized "arthritic-type" pain despite relief of their mechanical symptoms. To date, there are no published studies analyzing if this treatment is better than no treatment in this group of patients. We would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.
- Conditions
- Arthralgia
- Being tested
- Hylan G-F 20, Sham Injection
- Keywords
- Arthralgia, Viscosupplementation, Knee, Menisci, Tibial, Surgery, Outpatient
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylan G-F 20Drug
Also called Synvisc One
6 ml intra-articular injection given once. The injection takes approximately 15 seconds.
Sham InjectionOther
A needle will be inserted through the knee capsule but no medication will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Hylan G-F 20 | Experimental | Single injection of Hylan G-F 20 into the affected knee. Receives: Drug: Hylan G-F 20 |
| Sham Injection | Sham comparator | A needle will be inserted through the knee capsule but no medication will be injected. Receives: Other: Sham Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scale
Measured: 0, 2, 6, 12, 18, 26 weeks
Secondary outcomes (3)
Knee injury and Osteoarthritis Outcome Score
Measured: 0, 2, 6, 12, 18, 26 weeks
SF-36® Health Survey
Measured: 0, 2, 6, 12, 18, 26 weeks
Physical Examination
Measured: 0, 2, 6, 12, 18, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Patients did not meet inclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthralgiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grant Jones
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor-investigator, Grant Jones, Ohio State University
- Investigators
- Grant Jones, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971074
- Sponsor's protocol ID
- 2009H0156
- Status last verified
- Feb 2021
- First submitted
- 2 Sep 2009
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Viscosupplementation for the Treatment of Patients With Persistent Non-mechanical Pain Status-post Partial Menisectomy
- ClinicalTrials.gov ID
- NCT00971074
- Acronym / sponsor ID
- 2009H0156
- Conditions
- Arthralgia
- Keywords
- Arthralgia, Viscosupplementation, Knee, Menisci, Tibial, Surgery, Outpatient
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients did not meet inclusion criteria.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Grant JonesUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Sep 2009 (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 investigators' objective is to analyze a group of patients who have had a partial meniscectomy but continue to have knee pain after surgery with a double-blind, randomized prospective study comparing the use of Hylan G-F 20(single injection of a viscosupplementation) versus placebo injection. The investigators would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.
Detailed description
A great majority of patients who have a partial menisectomy for mechanical symptoms do well with full return of function without pain. There is a sub-group of patients who are found to have Grade II- III chondromalacia lesions (deemed arthritic) at the time of surgery that have persistent generalized "arthritic-type" pain despite relief of their mechanical symptoms. To date, there are no published studies analyzing if this treatment is better than no treatment in this group of patients. We would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hylan G-F 20 | Experimental | Drug: Hylan G-F 20Single injection of Hylan G-F 20 into the affected knee. |
| Sham Injection | Sham comparator | Other: Sham InjectionA needle will be inserted through the knee capsule but no medication will be injected. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-60
- S/P partial medial and/or lateral partial meniscectomy
- Pre-operative MRI diagnosed meniscal tear
- Diffuse, non-focal arthroscopically diagnosed ICRS Grade II or III chondromalacia. (used to determine the presence of tibiofemoral osteoarthritis)
- Baseline VAS pain score between 50 and 80mm.
Key exclusion criteria (25 listed)
- Bilateral arthroscopy (within 6 months pre- and post- initial VAS score.
- Complete meniscectomy
- Microfracture (via drilling, picking, abrading, thermal or radiofrequency or any procedure that violates the subchondral plate)
- Focal chondral lesion visualized on arthroscopy or any focal cartilage procedure (e.g. ACI, OATS, mosaicplasty, etc)
- Concomitant ligamentous injury or repair
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 |
|---|---|---|
| Hylan G-F 20Also: Synvisc One6 ml intra-articular injection given once. The injection takes approximately 15 seconds. | Drug | Hylan G-F 20 |
| Sham InjectionA needle will be inserted through the knee capsule but no medication will be injected. | Other | Sham Injection |
Primary outcome
VAS pain scale
Time frame: 0, 2, 6, 12, 18, 26 weeks
3 secondary outcomes
Knee injury and Osteoarthritis Outcome Score
Time frame: 0, 2, 6, 12, 18, 26 weeks
SF-36® Health Survey
Time frame: 0, 2, 6, 12, 18, 26 weeks
Physical Examination
Time frame: 0, 2, 6, 12, 18, 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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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.
Grant Jones, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hylan G-F 20 in people with Arthralgia, run by Grant Jones at 1 site in United States.
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 7 inclusion and 25 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: withdrawn, as of the sponsor's last update on 25 Feb 2021. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
VAS pain scale (time frame: 0, 2, 6, 12, 18, 26 weeks). 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 25 Feb 2021.