OsteoarthritisPhase 3NCT00398866
A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
A Phase 3 study testing Synvisc (Hylan G-F20; hyaluronan injection), Bupivicaine (local anesthesia injection) and Kenalog (triamcinolone; corticosteroid injection) in people with Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Synvisc (Hylan G-F20; hyaluronan injection), Bupivicaine (local anesthesia injection) and Kenalog (triamcinolone; corticosteroid injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Mar 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of osteophytes or sclerosis at the carpometacarpal (CMC) joint
- Complaint of unacceptable pain despite modification of activity and a therapeutic dose of nonsteroidal anti-inflammatory drugs (NSAIDS), if tolerated
- If bilateral disease, only the most severely involved hand (as defined by the visual analog scale [VAS] for pain) will be entered in the study
- Able to follow instructions and complete questionnaires
- Failed conservative therapy with NSAIDS or COX-2 inhibitors
- Unable to tolerate COX-2 inhibitors
Who cannot join
- Previous traumatic dislocation, ligament tear, or fracture of the thumb in the affected hand
- Previous hand surgery on the affected hand
- Known hand comorbidities (e.g., active carpal tunnel syndrome, de Quervains tenosynovitis, etc.)
- Systemic rheumatic disease
- Bleeding diatheses or anti-coagulation
- Allergies to steroids, chicken products, bupivicaine, or adhesive (e.g., double-sided tape)
Show all 17Show fewer
- Current use of oral or intravenous steroids
- Active systemic malignancies
- Hyaluronan injection in the target CMC joint in the last 6 months
- Steroid or hyaluronan injection in any other joint in the last 6 months
- Insulin dependent diabetes mellitus (IDDM)
- Active infection
- Pain in the index joint that is more than 40 out of 100 on a VAS Pain scale
- End Stage CMC osteoarthritis, equivalent to bone on bone, Kellgren and Lawrence Stage IV
- Grade 3 or 4 Eaton and Litter (E+L) Classification
- E+L 3: Advanced joint distraction, subchondral cysts, and sclerosis
- E+L 4: Involvement of several joint surfaces
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial
Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids and local anesthetic.
The principle hypothesis is that treating osteoarthritis at the carpometacarpophalangeal (CMC) joint with injectable hyaluronan will results in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections (local anesthetic) or with corticosteroid injections. Treating CMC osteoarthritis with corticosteroid injections will result in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections. Patients with worse pre-treatment function will have less improvement and worse post-treatment results after administration of corticosteroid or hyaluronan.
Read the detailed description
Osteoarthritis involves a wearing down of the cartilage within a joint. It can affect any joint in the body, but it most commonly affects joints in the hands, hips, knees, and spine. Over the last few years, a new medicine called hyaluronan has been used for treating osteoarthritis. Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids and local anesthetic. Specifically, the study will evaluate pain relief, patient satisfaction, and functional outcomes among participants.
Participation in this study will last 26 weeks. Screening will include a questionnaire and an x-ray of the affected thumb. Eligible participants will then be randomly assigned to one of three treatments: two hyaluronan injections, one corticosteroid injection plus one local anesthetic injection, or two local anesthetic injections. Participants will receive the injections at the base of their thumb, and the first injection will be followed by the second injection a week later. There will be five study visits that will occur at baseline and Weeks 2, 4, 12, and 26. All study visits will include questionnaires, and except for the Week 2 study visit, they will also include an examination and evaluation of the affected thumb. Photographs of the thumb will be taken at baseline. The injections will occur at baseline and Week 2. At Weeks 8 and 20, questionnaires will be mailed to participants for them to complete. Upon completing the study, participants will have the option of receiving continued treatment with another round of hyaluronic injections.
- Conditions
- Osteoarthritis
- Being tested
- Synvisc (Hylan G-F20; hyaluronan injection), Bupivicaine (local anesthesia injection), Kenalog (triamcinolone; corticosteroid injection)
- Keywords
- Hyaluronan, Carpometacarpal, Outcomes, Carpometacarpal Joints
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc (Hylan G-F20; hyaluronan injection)Drug
Also called Synvisc, Hyalgan, Hyaluronic Acid
1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
Bupivicaine (local anesthesia injection)Drug
1 ml of bupivicaine 0.5% injected once a week for 2 weeks
Kenalog (triamcinolone; corticosteroid injection)Drug
1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bupivicaine (local anesthetic) Receives: Drug: Bupivicaine (local anesthesia injection) |
| 2 | Active comparator | Corticosteroid (trimcinolone (Kenalog) 40 mg) Receives: Drug: Kenalog (triamcinolone; corticosteroid injection) |
| 3 | Experimental | Synvisc Receives: Drug: Synvisc (Hylan G-F20; hyaluronan injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analogue Scale (VAS)
Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.
Measured: Baseline, 26 Weeks
Secondary outcomes (1)
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire measures degree of disability on a scale of 0 to 100, with a higher score indicating greater disability.
Measured: Baseline, 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Lisa A. Mandl, MD, MPH, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398866
- Sponsor's protocol ID
- K23AR050607
- Other IDs
- K23AR050607, 5K23AR050607-04, 26043
- Status last verified
- Jul 2017
- First submitted
- 10 Nov 2006
- Last updated
- 7 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00398866
- Acronym / sponsor ID
- K23AR050607
- Conditions
- Osteoarthritis
- Keywords
- Hyaluronan, Carpometacarpal, Outcomes, Carpometacarpal Joints
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Genzyme, a Sanofi Company
- Study start
- Aug 2006
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 14 Nov 2006 (estimated)
- Results
- Posted 7 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids and local anesthetic.
The principle hypothesis is that treating osteoarthritis at the carpometacarpophalangeal (CMC) joint with injectable hyaluronan will results in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections (local anesthetic) or with corticosteroid injections. Treating CMC osteoarthritis with corticosteroid injections will result in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections. Patients with worse pre-treatment function will have less improvement and worse post-treatment results after administration of corticosteroid or hyaluronan.
Detailed description
Osteoarthritis involves a wearing down of the cartilage within a joint. It can affect any joint in the body, but it most commonly affects joints in the hands, hips, knees, and spine. Over the last few years, a new medicine called hyaluronan has been used for treating osteoarthritis. Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids and local anesthetic. Specifically, the study will evaluate pain relief, patient satisfaction, and functional outcomes among participants.
Participation in this study will last 26 weeks. Screening will include a questionnaire and an x-ray of the affected thumb. Eligible participants will then be randomly assigned to one of three treatments: two hyaluronan injections, one corticosteroid injection plus one local anesthetic injection, or two local anesthetic injections. Participants will receive the injections at the base of their thumb, and the first injection will be followed by the second injection a week later. There will be five study visits that will occur at baseline and Weeks 2, 4, 12, and 26. All study visits will include questionnaires, and except for the Week 2 study visit, they will also include an examination and evaluation of the affected thumb. Photographs of the thumb will be taken at baseline. The injections will occur at baseline and Week 2. At Weeks 8 and 20, questionnaires will be mailed to participants for them to complete. Upon completing the study, participants will have the option of receiving continued treatment with another round of hyaluronic injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Bupivicaine (local anesthesia injection)Bupivicaine (local anesthetic) |
| 2 | Active comparator | Drug: Kenalog (triamcinolone; corticosteroid injection)Corticosteroid (trimcinolone (Kenalog) 40 mg) |
| 3 | Experimental | Drug: Synvisc (Hylan G-F20; hyaluronan injection)Synvisc |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of osteophytes or sclerosis at the carpometacarpal (CMC) joint
- Complaint of unacceptable pain despite modification of activity and a therapeutic dose of nonsteroidal anti-inflammatory drugs (NSAIDS), if tolerated
- If bilateral disease, only the most severely involved hand (as defined by the visual analog scale [VAS] for pain) will be entered in the study
- Able to follow instructions and complete questionnaires
- Failed conservative therapy with NSAIDS or COX-2 inhibitors
Key exclusion criteria (17 listed)
- Previous traumatic dislocation, ligament tear, or fracture of the thumb in the affected hand
- Previous hand surgery on the affected hand
- Known hand comorbidities (e.g., active carpal tunnel syndrome, de Quervains tenosynovitis, etc.)
- Systemic rheumatic disease
- Bleeding diatheses or anti-coagulation
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 |
|---|---|---|
| Synvisc (Hylan G-F20; hyaluronan injection)Also: Synvisc, Hyalgan, Hyaluronic Acid1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks | Drug | 3 |
| Bupivicaine (local anesthesia injection)1 ml of bupivicaine 0.5% injected once a week for 2 weeks | Drug | 1 |
| Kenalog (triamcinolone; corticosteroid injection)1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation | Drug | 2 |
Primary outcome
Pain Visual Analogue Scale (VAS)
Time frame: Baseline, 26 Weeks
Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.
1 secondary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: Baseline, 26 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lisa A. Mandl, MD, MPH principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Synvisc (Hylan G-F20; hyaluronan injection), Bupivicaine (local anesthesia injection) and Kenalog (triamcinolone; corticosteroid injection) in people with Osteoarthritis, run by Hospital for Special Surgery, New York 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 6 inclusion and 17 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 7 Jul 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 7 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Visual Analogue Scale (VAS) (time frame: Baseline, 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 7 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.