Intra-articular hylastan versus steroid for knee osteoarthritis
Purpose To assess the efficacy and safety of one and two intra-articular (IA) injections of the new viscosupplement, hylastan, compared with a single IA corticosteroid injection for pain due to knee osteoarthritis (OA). Hylastan is a high-molecular-weight hyaluronan derivative prepared from bacteria...
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| Veröffentlicht in: | Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA sports traumatology, arthroscopy : official journal of the ESSKA, 2014-07, Vol.22 (7), p.1684-1692 |
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| creator | Housman, Lawrence Arden, Nigel Schnitzer, Thomas J. Birbara, Charles Conrozier, Thierry Skrepnik, Nebojsa Wei, Nathan Bockow, Barry Waddell, David Tahir, Hasan Hammond, Anthony Goupille, Philippe Sanson, Bernd-Jan Elkins, Clare Bailleul, François |
| description | Purpose
To assess the efficacy and safety of one and two intra-articular (IA) injections of the new viscosupplement, hylastan, compared with a single IA corticosteroid injection for pain due to knee osteoarthritis (OA). Hylastan is a high-molecular-weight hyaluronan derivative prepared from bacterial fermented sodium hyaluronate that was developed to remain in the joint for longer than most other viscosupplements.
Methods
This 6-month, double-blind, randomized, parallel group, multicenter trial enrolled patients aged ≥40 years who met American College of Rheumatology criteria for knee OA and had continued pain despite conservative treatment. Patients were randomized 1:1:1 to one of three arms: 2 × 4 mL hylastan (
n
= 129; arthrocentesis then IA hylastan Day 0, same treatment Week 2); 1 × 4 mL hylastan (
n
= 130; arthrocentesis then IA hylastan Day 0, arthrocentesis only Week 2); steroid (
n
= 132; arthrocentesis then IA methylprednisolone acetate 40 mg Day 0, arthrocentesis only Week 2). Participants and evaluators were blinded to treatment. The primary clinical outcome measure was change from baseline in WOMAC A pain score over all postbaseline visits to Week 26.
Results
Statistically significant pain reduction was observed in all three arms, with similar mean (95 % CI) changes in WOMAC A: 2 × 4 mL hylastan −0.9 (−1.0, −0.7); 1 × 4 mL hylastan −0.8 (−0.9, −0.7); steroid −0.9 (−1.0, −0.8); all
P
|
| doi_str_mv | 10.1007/s00167-013-2438-7 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1554950709</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1537184856</sourcerecordid><originalsourceid>FETCH-LOGICAL-c541t-ff6af4d071a82f9e8aa99acdaf657b642f1d83db48fdbbc9682b5dfa7b868e6c3</originalsourceid><addsrcrecordid>eNqNkU1LAzEQhoMotlZ_gBdZ8OIlmu-Pk0jxCwpe9Byyu4ndut3UZFfovzelVUQQPM0w88w7zLwAnGJ0iRGSVwkhLCREmELCqIJyD4wxoxRKyuQ-GCPNCCSIixE4SmmBUE6ZPgQjQhmWhIoxuH7s-mihjX1TDa2NxXzd2tTbrvhwMQ2pSL2LoakLH2Lx1jlXhFwJmZ_Hpm_SMTjwtk3uZBcn4OXu9nn6AGdP94_TmxmsOMM99F5Yz2oksVXEa6es1dpWtfWCy1Iw4nGtaF0y5euyrLRQpOS1t7JUQjlR0Qm42OquYngfXOrNskmVa1vbuTAkgzlnmiOJ9D9QKrFiiouMnv9CF2GIXT5kQ3HNmRI0U3hLVTGkFJ03q9gsbVwbjMzGCLM1wmQjzMYII_PM2U55KJeu_p74-nwGyBZIudW9uvhj9Z-qnw7pk4c</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1535954863</pqid></control><display><type>article</type><title>Intra-articular hylastan versus steroid for knee osteoarthritis</title><source>MEDLINE</source><source>SpringerNature Journals</source><source>Access via Wiley Online Library</source><creator>Housman, Lawrence ; Arden, Nigel ; Schnitzer, Thomas J. ; Birbara, Charles ; Conrozier, Thierry ; Skrepnik, Nebojsa ; Wei, Nathan ; Bockow, Barry ; Waddell, David ; Tahir, Hasan ; Hammond, Anthony ; Goupille, Philippe ; Sanson, Bernd-Jan ; Elkins, Clare ; Bailleul, François</creator><creatorcontrib>Housman, Lawrence ; Arden, Nigel ; Schnitzer, Thomas J. ; Birbara, Charles ; Conrozier, Thierry ; Skrepnik, Nebojsa ; Wei, Nathan ; Bockow, Barry ; Waddell, David ; Tahir, Hasan ; Hammond, Anthony ; Goupille, Philippe ; Sanson, Bernd-Jan ; Elkins, Clare ; Bailleul, François</creatorcontrib><description>Purpose
To assess the efficacy and safety of one and two intra-articular (IA) injections of the new viscosupplement, hylastan, compared with a single IA corticosteroid injection for pain due to knee osteoarthritis (OA). Hylastan is a high-molecular-weight hyaluronan derivative prepared from bacterial fermented sodium hyaluronate that was developed to remain in the joint for longer than most other viscosupplements.
Methods
This 6-month, double-blind, randomized, parallel group, multicenter trial enrolled patients aged ≥40 years who met American College of Rheumatology criteria for knee OA and had continued pain despite conservative treatment. Patients were randomized 1:1:1 to one of three arms: 2 × 4 mL hylastan (
n
= 129; arthrocentesis then IA hylastan Day 0, same treatment Week 2); 1 × 4 mL hylastan (
n
= 130; arthrocentesis then IA hylastan Day 0, arthrocentesis only Week 2); steroid (
n
= 132; arthrocentesis then IA methylprednisolone acetate 40 mg Day 0, arthrocentesis only Week 2). Participants and evaluators were blinded to treatment. The primary clinical outcome measure was change from baseline in WOMAC A pain score over all postbaseline visits to Week 26.
Results
Statistically significant pain reduction was observed in all three arms, with similar mean (95 % CI) changes in WOMAC A: 2 × 4 mL hylastan −0.9 (−1.0, −0.7); 1 × 4 mL hylastan −0.8 (−0.9, −0.7); steroid −0.9 (−1.0, −0.8); all
P
< 0.0001 versus baseline. Changes in secondary outcomes (OMERACT-OARSI and WOMAC A responder rates, patient/clinical observer global assessments, and WOMAC A1 walking pain) were similar in all three arms. Target knee adverse events were comparable for all treatments.
Conclusions
Both IA hylastan injection regimens were effective in relieving pain with an acceptable safety profile. IA hylastan did not show a difference versus IA corticosteroid; therefore, the hypothesis of superior pain relief was not met. Further research is needed to compare the efficacy and safety of hylastan with other viscosupplements.
Level of evidence
Therapeutic study, Level I.</description><identifier>ISSN: 0942-2056</identifier><identifier>EISSN: 1433-7347</identifier><identifier>DOI: 10.1007/s00167-013-2438-7</identifier><identifier>PMID: 23417236</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adrenal Cortex Hormones - administration & dosage ; Adrenal Cortex Hormones - therapeutic use ; Adult ; Aged ; Aged, 80 and over ; Arthritis ; Cartilage ; Double-Blind Method ; Female ; Humans ; Hyaluronic acid ; Hyaluronic Acid - administration & dosage ; Hyaluronic Acid - therapeutic use ; Hypotheses ; Injections, Intra-Articular ; Knee ; Male ; Medicine ; Medicine & Public Health ; Methylprednisolone - administration & dosage ; Methylprednisolone - therapeutic use ; Middle Aged ; Molecular weight ; Orthopedics ; Osteoarthritis ; Osteoarthritis, Knee - drug therapy ; Pain ; Pain - drug therapy ; Pain Management ; Pain Measurement ; Patients ; Prospective Studies ; Quality of life ; Steroids ; Treatment Outcome ; Viscosupplements - administration & dosage ; Viscosupplements - therapeutic use</subject><ispartof>Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA, 2014-07, Vol.22 (7), p.1684-1692</ispartof><rights>Springer-Verlag Berlin Heidelberg 2013</rights><rights>Springer-Verlag Berlin Heidelberg 2014</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c541t-ff6af4d071a82f9e8aa99acdaf657b642f1d83db48fdbbc9682b5dfa7b868e6c3</citedby><cites>FETCH-LOGICAL-c541t-ff6af4d071a82f9e8aa99acdaf657b642f1d83db48fdbbc9682b5dfa7b868e6c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00167-013-2438-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00167-013-2438-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23417236$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Housman, Lawrence</creatorcontrib><creatorcontrib>Arden, Nigel</creatorcontrib><creatorcontrib>Schnitzer, Thomas J.</creatorcontrib><creatorcontrib>Birbara, Charles</creatorcontrib><creatorcontrib>Conrozier, Thierry</creatorcontrib><creatorcontrib>Skrepnik, Nebojsa</creatorcontrib><creatorcontrib>Wei, Nathan</creatorcontrib><creatorcontrib>Bockow, Barry</creatorcontrib><creatorcontrib>Waddell, David</creatorcontrib><creatorcontrib>Tahir, Hasan</creatorcontrib><creatorcontrib>Hammond, Anthony</creatorcontrib><creatorcontrib>Goupille, Philippe</creatorcontrib><creatorcontrib>Sanson, Bernd-Jan</creatorcontrib><creatorcontrib>Elkins, Clare</creatorcontrib><creatorcontrib>Bailleul, François</creatorcontrib><title>Intra-articular hylastan versus steroid for knee osteoarthritis</title><title>Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA</title><addtitle>Knee Surg Sports Traumatol Arthrosc</addtitle><addtitle>Knee Surg Sports Traumatol Arthrosc</addtitle><description>Purpose
To assess the efficacy and safety of one and two intra-articular (IA) injections of the new viscosupplement, hylastan, compared with a single IA corticosteroid injection for pain due to knee osteoarthritis (OA). Hylastan is a high-molecular-weight hyaluronan derivative prepared from bacterial fermented sodium hyaluronate that was developed to remain in the joint for longer than most other viscosupplements.
Methods
This 6-month, double-blind, randomized, parallel group, multicenter trial enrolled patients aged ≥40 years who met American College of Rheumatology criteria for knee OA and had continued pain despite conservative treatment. Patients were randomized 1:1:1 to one of three arms: 2 × 4 mL hylastan (
n
= 129; arthrocentesis then IA hylastan Day 0, same treatment Week 2); 1 × 4 mL hylastan (
n
= 130; arthrocentesis then IA hylastan Day 0, arthrocentesis only Week 2); steroid (
n
= 132; arthrocentesis then IA methylprednisolone acetate 40 mg Day 0, arthrocentesis only Week 2). Participants and evaluators were blinded to treatment. The primary clinical outcome measure was change from baseline in WOMAC A pain score over all postbaseline visits to Week 26.
Results
Statistically significant pain reduction was observed in all three arms, with similar mean (95 % CI) changes in WOMAC A: 2 × 4 mL hylastan −0.9 (−1.0, −0.7); 1 × 4 mL hylastan −0.8 (−0.9, −0.7); steroid −0.9 (−1.0, −0.8); all
P
< 0.0001 versus baseline. Changes in secondary outcomes (OMERACT-OARSI and WOMAC A responder rates, patient/clinical observer global assessments, and WOMAC A1 walking pain) were similar in all three arms. Target knee adverse events were comparable for all treatments.
Conclusions
Both IA hylastan injection regimens were effective in relieving pain with an acceptable safety profile. IA hylastan did not show a difference versus IA corticosteroid; therefore, the hypothesis of superior pain relief was not met. Further research is needed to compare the efficacy and safety of hylastan with other viscosupplements.
Level of evidence
Therapeutic study, Level I.</description><subject>Adrenal Cortex Hormones - administration & dosage</subject><subject>Adrenal Cortex Hormones - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Arthritis</subject><subject>Cartilage</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Hyaluronic acid</subject><subject>Hyaluronic Acid - administration & dosage</subject><subject>Hyaluronic Acid - therapeutic use</subject><subject>Hypotheses</subject><subject>Injections, Intra-Articular</subject><subject>Knee</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Methylprednisolone - administration & dosage</subject><subject>Methylprednisolone - therapeutic use</subject><subject>Middle Aged</subject><subject>Molecular weight</subject><subject>Orthopedics</subject><subject>Osteoarthritis</subject><subject>Osteoarthritis, Knee - drug therapy</subject><subject>Pain</subject><subject>Pain - drug therapy</subject><subject>Pain Management</subject><subject>Pain Measurement</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Quality of life</subject><subject>Steroids</subject><subject>Treatment Outcome</subject><subject>Viscosupplements - administration & dosage</subject><subject>Viscosupplements - therapeutic use</subject><issn>0942-2056</issn><issn>1433-7347</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNqNkU1LAzEQhoMotlZ_gBdZ8OIlmu-Pk0jxCwpe9Byyu4ndut3UZFfovzelVUQQPM0w88w7zLwAnGJ0iRGSVwkhLCREmELCqIJyD4wxoxRKyuQ-GCPNCCSIixE4SmmBUE6ZPgQjQhmWhIoxuH7s-mihjX1TDa2NxXzd2tTbrvhwMQ2pSL2LoakLH2Lx1jlXhFwJmZ_Hpm_SMTjwtk3uZBcn4OXu9nn6AGdP94_TmxmsOMM99F5Yz2oksVXEa6es1dpWtfWCy1Iw4nGtaF0y5euyrLRQpOS1t7JUQjlR0Qm42OquYngfXOrNskmVa1vbuTAkgzlnmiOJ9D9QKrFiiouMnv9CF2GIXT5kQ3HNmRI0U3hLVTGkFJ03q9gsbVwbjMzGCLM1wmQjzMYII_PM2U55KJeu_p74-nwGyBZIudW9uvhj9Z-qnw7pk4c</recordid><startdate>20140701</startdate><enddate>20140701</enddate><creator>Housman, Lawrence</creator><creator>Arden, Nigel</creator><creator>Schnitzer, Thomas J.</creator><creator>Birbara, Charles</creator><creator>Conrozier, Thierry</creator><creator>Skrepnik, Nebojsa</creator><creator>Wei, Nathan</creator><creator>Bockow, Barry</creator><creator>Waddell, David</creator><creator>Tahir, Hasan</creator><creator>Hammond, Anthony</creator><creator>Goupille, Philippe</creator><creator>Sanson, Bernd-Jan</creator><creator>Elkins, Clare</creator><creator>Bailleul, François</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>7QP</scope></search><sort><creationdate>20140701</creationdate><title>Intra-articular hylastan versus steroid for knee osteoarthritis</title><author>Housman, Lawrence ; Arden, Nigel ; Schnitzer, Thomas J. ; Birbara, Charles ; Conrozier, Thierry ; Skrepnik, Nebojsa ; Wei, Nathan ; Bockow, Barry ; Waddell, David ; Tahir, Hasan ; Hammond, Anthony ; Goupille, Philippe ; Sanson, Bernd-Jan ; Elkins, Clare ; Bailleul, François</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c541t-ff6af4d071a82f9e8aa99acdaf657b642f1d83db48fdbbc9682b5dfa7b868e6c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adrenal Cortex Hormones - administration & dosage</topic><topic>Adrenal Cortex Hormones - therapeutic use</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Arthritis</topic><topic>Cartilage</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Hyaluronic acid</topic><topic>Hyaluronic Acid - administration & dosage</topic><topic>Hyaluronic Acid - therapeutic use</topic><topic>Hypotheses</topic><topic>Injections, Intra-Articular</topic><topic>Knee</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Methylprednisolone - administration & dosage</topic><topic>Methylprednisolone - therapeutic use</topic><topic>Middle Aged</topic><topic>Molecular weight</topic><topic>Orthopedics</topic><topic>Osteoarthritis</topic><topic>Osteoarthritis, Knee - drug therapy</topic><topic>Pain</topic><topic>Pain - drug therapy</topic><topic>Pain Management</topic><topic>Pain Measurement</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>Quality of life</topic><topic>Steroids</topic><topic>Treatment Outcome</topic><topic>Viscosupplements - administration & dosage</topic><topic>Viscosupplements - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Housman, Lawrence</creatorcontrib><creatorcontrib>Arden, Nigel</creatorcontrib><creatorcontrib>Schnitzer, Thomas J.</creatorcontrib><creatorcontrib>Birbara, Charles</creatorcontrib><creatorcontrib>Conrozier, Thierry</creatorcontrib><creatorcontrib>Skrepnik, Nebojsa</creatorcontrib><creatorcontrib>Wei, Nathan</creatorcontrib><creatorcontrib>Bockow, Barry</creatorcontrib><creatorcontrib>Waddell, David</creatorcontrib><creatorcontrib>Tahir, Hasan</creatorcontrib><creatorcontrib>Hammond, Anthony</creatorcontrib><creatorcontrib>Goupille, Philippe</creatorcontrib><creatorcontrib>Sanson, Bernd-Jan</creatorcontrib><creatorcontrib>Elkins, Clare</creatorcontrib><creatorcontrib>Bailleul, François</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>Calcium & Calcified Tissue Abstracts</collection><jtitle>Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Housman, Lawrence</au><au>Arden, Nigel</au><au>Schnitzer, Thomas J.</au><au>Birbara, Charles</au><au>Conrozier, Thierry</au><au>Skrepnik, Nebojsa</au><au>Wei, Nathan</au><au>Bockow, Barry</au><au>Waddell, David</au><au>Tahir, Hasan</au><au>Hammond, Anthony</au><au>Goupille, Philippe</au><au>Sanson, Bernd-Jan</au><au>Elkins, Clare</au><au>Bailleul, François</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intra-articular hylastan versus steroid for knee osteoarthritis</atitle><jtitle>Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA</jtitle><stitle>Knee Surg Sports Traumatol Arthrosc</stitle><addtitle>Knee Surg Sports Traumatol Arthrosc</addtitle><date>2014-07-01</date><risdate>2014</risdate><volume>22</volume><issue>7</issue><spage>1684</spage><epage>1692</epage><pages>1684-1692</pages><issn>0942-2056</issn><eissn>1433-7347</eissn><abstract>Purpose
To assess the efficacy and safety of one and two intra-articular (IA) injections of the new viscosupplement, hylastan, compared with a single IA corticosteroid injection for pain due to knee osteoarthritis (OA). Hylastan is a high-molecular-weight hyaluronan derivative prepared from bacterial fermented sodium hyaluronate that was developed to remain in the joint for longer than most other viscosupplements.
Methods
This 6-month, double-blind, randomized, parallel group, multicenter trial enrolled patients aged ≥40 years who met American College of Rheumatology criteria for knee OA and had continued pain despite conservative treatment. Patients were randomized 1:1:1 to one of three arms: 2 × 4 mL hylastan (
n
= 129; arthrocentesis then IA hylastan Day 0, same treatment Week 2); 1 × 4 mL hylastan (
n
= 130; arthrocentesis then IA hylastan Day 0, arthrocentesis only Week 2); steroid (
n
= 132; arthrocentesis then IA methylprednisolone acetate 40 mg Day 0, arthrocentesis only Week 2). Participants and evaluators were blinded to treatment. The primary clinical outcome measure was change from baseline in WOMAC A pain score over all postbaseline visits to Week 26.
Results
Statistically significant pain reduction was observed in all three arms, with similar mean (95 % CI) changes in WOMAC A: 2 × 4 mL hylastan −0.9 (−1.0, −0.7); 1 × 4 mL hylastan −0.8 (−0.9, −0.7); steroid −0.9 (−1.0, −0.8); all
P
< 0.0001 versus baseline. Changes in secondary outcomes (OMERACT-OARSI and WOMAC A responder rates, patient/clinical observer global assessments, and WOMAC A1 walking pain) were similar in all three arms. Target knee adverse events were comparable for all treatments.
Conclusions
Both IA hylastan injection regimens were effective in relieving pain with an acceptable safety profile. IA hylastan did not show a difference versus IA corticosteroid; therefore, the hypothesis of superior pain relief was not met. Further research is needed to compare the efficacy and safety of hylastan with other viscosupplements.
Level of evidence
Therapeutic study, Level I.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>23417236</pmid><doi>10.1007/s00167-013-2438-7</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0942-2056 |
| ispartof | Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA, 2014-07, Vol.22 (7), p.1684-1692 |
| issn | 0942-2056 1433-7347 |
| language | eng |
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| source | MEDLINE; SpringerNature Journals; Access via Wiley Online Library |
| subjects | Adrenal Cortex Hormones - administration & dosage Adrenal Cortex Hormones - therapeutic use Adult Aged Aged, 80 and over Arthritis Cartilage Double-Blind Method Female Humans Hyaluronic acid Hyaluronic Acid - administration & dosage Hyaluronic Acid - therapeutic use Hypotheses Injections, Intra-Articular Knee Male Medicine Medicine & Public Health Methylprednisolone - administration & dosage Methylprednisolone - therapeutic use Middle Aged Molecular weight Orthopedics Osteoarthritis Osteoarthritis, Knee - drug therapy Pain Pain - drug therapy Pain Management Pain Measurement Patients Prospective Studies Quality of life Steroids Treatment Outcome Viscosupplements - administration & dosage Viscosupplements - therapeutic use |
| title | Intra-articular hylastan versus steroid for knee osteoarthritis |
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