OsteoarthritisPhase 2NCT00918736
Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis
A Phase 2 study testing sodium hyaluronate in people with Osteoarthritis, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
The aim of this study was to investigate the efficacy and safety of three weekly intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle Osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- sodium hyaluronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2007to Oct 2008
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were 18 years of age or older, reported unilateral ankle pain for at least 6 months and had either reported no significant benefit from conservative treatment (rest, physical therapy, orthoses or pain medications etc.) or were unable to tolerate side effects of medications
- ankle radiographs taken within 6 months were equivalent to grade 2 or 3 according to the Kellgren-Lawrence grading system (grade 2, definite osteophytes and possible narrowing of joint space; grade 3, moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour)22
- had a current total AOS score (described below) of > 3 and < 9 (possible range, 0-10)
- were normally active, not bedridden or confined to a wheelchair, and were able to walk 30 meters without the aid of a walker, crutches or cane
- were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (except for rescue medication) for the duration of the study
- did not receive physical therapy or trial of shoe modifications or orthotics during the study period
Who cannot join
- pregnant and lactating women
- bilateral ankle OA requiring treatment of both ankles
- chronic ankle instability
- lower leg trauma other than within the ankle
- previous orthopedic surgery on the spine, hip or knee
- presence of active joint infections of foot or ankle
Show all 12Show fewer
- previous surgery or arthroscopy on the ankle within 12 months
- intraarticular steroid or HA injection in the treated ankle within the past 6 months
- treatment with anticoagulants or immunosuppressives
- history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
- history of avian protein allergy
- presence of other comorbidity (neoplasm, diabetes mellitus, paresis, recent trauma, etc) or poor health status that would interfere with the clinical assessments during the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Veterans General Hospital, Kaohsiung, Taiwan
Kaohsiung City, 813
About this study
Official title: Hyaluronans in the Treatment of Ankle Osteoarthritis
The aim of this study was to investigate the efficacy and safety of three weekly intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle Osteoarthritis (OA).
Read the detailed description
Viscosupplementation with 3 to 5 weekly hyaluronate injections is a well-established treatment option in knee osteoarthritis. Previous studies reported that five weekly hyaluronate injections were safe and effective for the treatment of ankle osteoarthritis. However, the effect of three weekly injections has rarely been investigated. Besides, no study to date has assessed whether balance function would change after HA injections in patients with ankle OA. The purpose of this study was to evaluate the efficacy and safety of three weekly injections of sodium hyaluronate (Hyalgan) in patients with unilateral ankle osteoarthritis. Pain, physical function and balance will be assessed as parameters for the effectiveness.
- Conditions
- Osteoarthritis
- Being tested
- sodium hyaluronate
- Keywords
- Ankle joint, Balance, Hyaluronic acid, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium hyaluronateDrug
3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
| Study group | Role | What they receive |
|---|---|---|
| hyaluronate injection | Experimental | All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints. Receives: Drug: sodium hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months
The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable
Measured: baseline and 6 months
Secondary outcomes (6)
The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score
The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment
Measured: 6 months
Ankle Sagittal Range of Motion
Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.
Measured: 6 months
Four Clinical Balance Tests
Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed " Up-and-Go" test (TUG) ,Berg Balance Scale (BBS)
Measured: 6 months
the Level of Global Satisfaction Based on a 7-point Categorical Scale
The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.
Measured: 6 months
Systemic and Local Adverse Events Recording
he occurrence of systemic and local adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded on a diary card
Measured: 6 months
Rescue Acetaminophen Consumption
The use of all analgesic medication during the study period was recorded on a diary card by the patient.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionOct 2008
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Shu-Fen Sun, MD, Principal investigator, Veterans General Hospital, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918736
- Sponsor's protocol ID
- NSC96-2314-B-075B-006
- Status last verified
- Jun 2009
- First submitted
- 16 Mar 2009
- Last updated
- 17 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Salk RS, Chang TJ, D'Costa WF, Soomekh DJ, Grogan KA. Sodium hyaluronate in the treatment of osteoarthritis of the ankle: a controlled, randomized, double-blind pilot study. J Bone Joint Surg Am. 2006 Feb;88(2):295-302. doi: 10.2106/JBJS.E.00193.
PubMed 16452740Sun SF, Chou YJ, Hsu CW, Hwang CW, Hsu PT, Wang JL, Hsu YW, Chou MC. Efficacy of intra-articular hyaluronic acid in patients with osteoarthritis of the ankle: a prospective study. Osteoarthritis Cartilage. 2006 Sep;14(9):867-74. doi: 10.1016/j.joca.2006.03.003. Epub 2006 Apr 24.
PubMed 16635582Cohen MM, Altman RD, Hollstrom R, Hollstrom C, Sun C, Gipson B. Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Foot Ankle Int. 2008 Jul;29(7):657-63. doi: 10.3113/FAI.2008.0657.
PubMed 18785414
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronans in the Treatment of Ankle Osteoarthritis
- ClinicalTrials.gov ID
- NCT00918736
- Acronym / sponsor ID
- NSC96-2314-B-075B-006
- Conditions
- Osteoarthritis
- Keywords
- Ankle joint, Balance, Hyaluronic acid, Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 11 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to investigate the efficacy and safety of three weekly intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle Osteoarthritis (OA).
Detailed description
Viscosupplementation with 3 to 5 weekly hyaluronate injections is a well-established treatment option in knee osteoarthritis. Previous studies reported that five weekly hyaluronate injections were safe and effective for the treatment of ankle osteoarthritis. However, the effect of three weekly injections has rarely been investigated. Besides, no study to date has assessed whether balance function would change after HA injections in patients with ankle OA. The purpose of this study was to evaluate the efficacy and safety of three weekly injections of sodium hyaluronate (Hyalgan) in patients with unilateral ankle osteoarthritis. Pain, physical function and balance will be assessed as parameters for the effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyaluronate injection | Experimental | Drug: sodium hyaluronateAll patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- were 18 years of age or older, reported unilateral ankle pain for at least 6 months and had either reported no significant benefit from conservative treatment (rest, physical therapy, orthoses or pain medications etc.) or were unable to tolerate side effects of medications
- ankle radiographs taken within 6 months were equivalent to grade 2 or 3 according to the Kellgren-Lawrence grading system (grade 2, definite osteophytes and possible narrowing of joint space; grade 3, moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour)22
- had a current total AOS score (described below) of > 3 and < 9 (possible range, 0-10)
- were normally active, not bedridden or confined to a wheelchair, and were able to walk 30 meters without the aid of a walker, crutches or cane
- were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (except for rescue medication) for the duration of the study
Key exclusion criteria (12 listed)
- pregnant and lactating women
- bilateral ankle OA requiring treatment of both ankles
- chronic ankle instability
- lower leg trauma other than within the ankle
- previous orthopedic surgery on the spine, hip or knee
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 |
|---|---|---|
| sodium hyaluronate3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints. | Drug | hyaluronate injection |
Primary outcome
Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months
Time frame: baseline and 6 months
The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable
6 secondary outcomes
The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score
Time frame: 6 months
Ankle Sagittal Range of Motion
Time frame: 6 months
Four Clinical Balance Tests
Time frame: 6 months
the Level of Global Satisfaction Based on a 7-point Categorical Scale
Time frame: 6 months
Systemic and Local Adverse Events Recording
Time frame: 6 months
Rescue Acetaminophen Consumption
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16452740Salk RS, Chang TJ, D'Costa WF, Soomekh DJ, Grogan KA. Sodium hyaluronate in the treatment of osteoarthritis of the ankle: a controlled, randomized, double-blind pilot study. J Bone Joint Surg Am. 2006 Feb;88(2):295-302. doi: 10.2106/JBJS.E.00193.
- Background: PubMed 16635582Sun SF, Chou YJ, Hsu CW, Hwang CW, Hsu PT, Wang JL, Hsu YW, Chou MC. Efficacy of intra-articular hyaluronic acid in patients with osteoarthritis of the ankle: a prospective study. Osteoarthritis Cartilage. 2006 Sep;14(9):867-74. doi: 10.1016/j.joca.2006.03.003. Epub 2006 Apr 24.
- Background: PubMed 18785414Cohen MM, Altman RD, Hollstrom R, Hollstrom C, Sun C, Gipson B. Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Foot Ankle Int. 2008 Jul;29(7):657-63. doi: 10.3113/FAI.2008.0657.
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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.
Shu-Fen Sun, MD principal investigator
Veterans General Hospital, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium hyaluronate in people with Osteoarthritis, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 12 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 17 Jun 2009. 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 Taiwan. 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 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?
Yes. Results are posted in the registry (first posted 11 Jun 2009). 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?
Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months (time frame: baseline and 6 months). 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 NCT00918736, which also lists 3 linked publications.
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 17 Jun 2009.