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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyaluronate injection | Experimental | All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium hyaluronate | Drug | 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu-Fen Sun, MD | Veterans General Hospital, Kaohsiung, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, Veterans General Hospital, Kaohsiung, Taiwan | Kaohsiung City | 813 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16452740 | Background | 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. | |
| 16635582 | Background | Sun 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. |
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One patient withdrew his consent and one had a fear of injection prior to receiving the first injection. Two patients withdrew from the study before the third injection (one because of an unrelated intercurrent illness and one moving to another city).
Fifty patients fulfilled the inclusion criteria and consented to take part in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyaluronate Injection | All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyaluronate Injection | All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The statistical analysis was done on completers. | Posted | Mean | Standard Deviation | score on a scale | baseline and 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyaluronate Injection | All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| brief post injection pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
One limitation includes the absence of a control group, thus the placebo effects associated with joint injections were not investigated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shu-Fen Sun | Veterans General Hospital, Kaohsiung, Taiwan | 886-73422121 | 4210 | sfsun.tw@yahoo.com.tw |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Ankle Sagittal Range of Motion | Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles. | 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) | 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. | 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 | 6 months |
| Rescue Acetaminophen Consumption | The use of all analgesic medication during the study period was recorded on a diary card by the patient. | 6 months |
| 18785414 | Background | Cohen 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. |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
|---|
| Participants |
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| Secondary | 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 | Not Posted | Oct 2009 | Mean | Standard Deviation | point | 6 months |
| Secondary | Ankle Sagittal Range of Motion | Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles. | Not Posted | Sep 2009 | Mean | Standard Deviation | degree | 6 months |
| Secondary | Four Clinical Balance Tests | Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed " Up-and-Go" test (TUG) ,Berg Balance Scale (BBS) | Not Posted | Sep 2009 | Mean | Standard Deviation | sec | 6 months |
| Secondary | 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. | Not Posted | Oct 2009 | Number | participants | 6 months |
| Secondary | 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 | Not Posted | Oct 2009 | Number | participants | 6 months |
| Secondary | Rescue Acetaminophen Consumption | The use of all analgesic medication during the study period was recorded on a diary card by the patient. | Not Posted | Oct 2009 | Mean | Standard Deviation | tablets | 6 months |
| 0 |
| 4 |
| local pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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