Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254)
Summary Objective To evaluate the clinical effectiveness of intraarticular IL-1 receptor antagonist (IL-1Ra) for anterior cruciate ligament (ACL) tear. Methods Eleven patients with acute ACL tear confirmed by magnetic resonance imaging (MRI) were randomized to receive a single intraarticular injecti...
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| Veröffentlicht in: | Osteoarthritis and cartilage 2012-04, Vol.20 (4), p.271-278 |
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| creator | Kraus, V.B Birmingham, J Stabler, T.V Feng, S Taylor, D.C Moorman, C.T Garrett, W.E Toth, A.P |
| description | Summary Objective To evaluate the clinical effectiveness of intraarticular IL-1 receptor antagonist (IL-1Ra) for anterior cruciate ligament (ACL) tear. Methods Eleven patients with acute ACL tear confirmed by magnetic resonance imaging (MRI) were randomized to receive a single intraarticular injection of IL-1Ra (anakinra 150 mg, n = 6) or equal volume of saline placebo (1 ml, n = 5). The double-blinded treatment was administered a mean 2 weeks after injury. Synovial fluid (SF) ( n = 9 patients) and sera (all patients) were available at baseline (prior to injection) and immediately prior to surgery (mean 35 days later) and analyzed for SF IL-1α, IL-1β, IL-1Ra and serum hyaluronan (HA), an indicator of synovial inflammation. The primary outcome, standardized Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, was obtained at 0 (baseline), 4, and 14 days after injection. Results Compared with placebo, the IL-1Ra group had substantially greater improvement in key outcomes over 14 days (KOOS pain P = 0.001; activities of daily living P = 0.0015; KOOS sports function P = 0.0026; KOOS quality of life (QOL) P = 0.0048; and total KOOS P |
| doi_str_mv | 10.1016/j.joca.2011.12.009 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_929121756</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S106345841200012X</els_id><sourcerecordid>929121756</sourcerecordid><originalsourceid>FETCH-LOGICAL-c520t-5a2e36db2bb64ba86cf642b7d55c1aa2200f6900cec03e888cc150b7a00aae0c3</originalsourceid><addsrcrecordid>eNp9kU-LFDEQxRtR3HX1C3iQ3NRDj5XqP9MjIsiw6sKgoCt4C9XV1ZLeTGdMuoXx7Ac3zawePHhKJbz3qPxelj3WsNKg6xfDavBMKwStVxpXAJs72bmuEPNNXRV30wx1kZdVU55lD2IcAKDQGu5nZ4i4LuoCz7Nfl30vPEXle2XHKRCFyfLsKKirnc4_kep9UMTzJIrGSYJNVw4zW0ovzn6jvYyTuhlFkn-Yw_GlIhVo7Pze_pROsU-p3rk0Hqzzk5qCJaeefdhep3UKxKp8_jC715OL8uj2vMi-vL283r7Pdx_fXW3f7HKuEKa8IpSi7lps27psqam5r0ts111VsSZCBOjrDQALQyFN0zDrCto1ARAJcHGRPT3lHoL_PkuczN5GFudoFD9Hs8GNRr2u6qTEk5KDjzFIbw7B7ikcjQazwDeDWeCbBb7RaBL8ZHpyGz-3e-n-Wv7QToJXJ4GkT_6wEkxkKyNLZ0MqwXTe_j__9T92dna0TO5GjhIHP4cx4TPaxGQwn5f6l_Z1AgMavxa_AadtqoE</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>929121756</pqid></control><display><type>article</type><title>Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254)</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Kraus, V.B ; Birmingham, J ; Stabler, T.V ; Feng, S ; Taylor, D.C ; Moorman, C.T ; Garrett, W.E ; Toth, A.P</creator><creatorcontrib>Kraus, V.B ; Birmingham, J ; Stabler, T.V ; Feng, S ; Taylor, D.C ; Moorman, C.T ; Garrett, W.E ; Toth, A.P</creatorcontrib><description>Summary Objective To evaluate the clinical effectiveness of intraarticular IL-1 receptor antagonist (IL-1Ra) for anterior cruciate ligament (ACL) tear. Methods Eleven patients with acute ACL tear confirmed by magnetic resonance imaging (MRI) were randomized to receive a single intraarticular injection of IL-1Ra (anakinra 150 mg, n = 6) or equal volume of saline placebo (1 ml, n = 5). The double-blinded treatment was administered a mean 2 weeks after injury. Synovial fluid (SF) ( n = 9 patients) and sera (all patients) were available at baseline (prior to injection) and immediately prior to surgery (mean 35 days later) and analyzed for SF IL-1α, IL-1β, IL-1Ra and serum hyaluronan (HA), an indicator of synovial inflammation. The primary outcome, standardized Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, was obtained at 0 (baseline), 4, and 14 days after injection. Results Compared with placebo, the IL-1Ra group had substantially greater improvement in key outcomes over 14 days (KOOS pain P = 0.001; activities of daily living P = 0.0015; KOOS sports function P = 0.0026; KOOS quality of life (QOL) P = 0.0048; and total KOOS P < 0.0001). There were no adverse reactions in either group. SF IL-1α ( P = 0.05) and serum HA ( P = 0.03), but not IL-1β, or IL-1Ra, decreased significantly in the IL-1Ra but not the placebo treated patients. Compared with placebo, IL-1α was borderline significantly different in the IL-1Ra treated group ( P = 0.06). Conclusions Administered within the first month following severe knee injury, IL-1Ra reduced knee pain and improved function over a 2-week interval. This promising proof of concept study provides a new paradigm for studies of acute joint injury and suggests that a larger follow-up study is warranted.</description><identifier>ISSN: 1063-4584</identifier><identifier>EISSN: 1522-9653</identifier><identifier>DOI: 10.1016/j.joca.2011.12.009</identifier><identifier>PMID: 22273632</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Activities of Daily Living ; Adult ; Anterior cruciate ligament ; Anterior Cruciate Ligament Injuries ; Biomarkers ; Biomarkers - metabolism ; Clinical trial ; Female ; Humans ; IL-1Ra ; Injections, Intra-Articular ; Interleukin 1 Receptor Antagonist Protein - administration & dosage ; Interleukin 1 Receptor Antagonist Protein - therapeutic use ; Joint injury ; Knee Injuries - complications ; Knee Injuries - diagnosis ; Knee Injuries - drug therapy ; Knee Injuries - rehabilitation ; Magnetic Resonance Imaging ; Male ; Pain - drug therapy ; Pain - etiology ; Pilot Projects ; Post-traumatic arthritis ; Quality of Life ; Recovery of Function ; Rheumatology ; Synovial Fluid - metabolism ; Trauma Severity Indices ; Treatment Outcome ; Young Adult</subject><ispartof>Osteoarthritis and cartilage, 2012-04, Vol.20 (4), p.271-278</ispartof><rights>Osteoarthritis Research Society International</rights><rights>2012 Osteoarthritis Research Society International</rights><rights>Copyright © 2012 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c520t-5a2e36db2bb64ba86cf642b7d55c1aa2200f6900cec03e888cc150b7a00aae0c3</citedby><cites>FETCH-LOGICAL-c520t-5a2e36db2bb64ba86cf642b7d55c1aa2200f6900cec03e888cc150b7a00aae0c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.joca.2011.12.009$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22273632$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kraus, V.B</creatorcontrib><creatorcontrib>Birmingham, J</creatorcontrib><creatorcontrib>Stabler, T.V</creatorcontrib><creatorcontrib>Feng, S</creatorcontrib><creatorcontrib>Taylor, D.C</creatorcontrib><creatorcontrib>Moorman, C.T</creatorcontrib><creatorcontrib>Garrett, W.E</creatorcontrib><creatorcontrib>Toth, A.P</creatorcontrib><title>Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254)</title><title>Osteoarthritis and cartilage</title><addtitle>Osteoarthritis Cartilage</addtitle><description>Summary Objective To evaluate the clinical effectiveness of intraarticular IL-1 receptor antagonist (IL-1Ra) for anterior cruciate ligament (ACL) tear. Methods Eleven patients with acute ACL tear confirmed by magnetic resonance imaging (MRI) were randomized to receive a single intraarticular injection of IL-1Ra (anakinra 150 mg, n = 6) or equal volume of saline placebo (1 ml, n = 5). The double-blinded treatment was administered a mean 2 weeks after injury. Synovial fluid (SF) ( n = 9 patients) and sera (all patients) were available at baseline (prior to injection) and immediately prior to surgery (mean 35 days later) and analyzed for SF IL-1α, IL-1β, IL-1Ra and serum hyaluronan (HA), an indicator of synovial inflammation. The primary outcome, standardized Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, was obtained at 0 (baseline), 4, and 14 days after injection. Results Compared with placebo, the IL-1Ra group had substantially greater improvement in key outcomes over 14 days (KOOS pain P = 0.001; activities of daily living P = 0.0015; KOOS sports function P = 0.0026; KOOS quality of life (QOL) P = 0.0048; and total KOOS P < 0.0001). There were no adverse reactions in either group. SF IL-1α ( P = 0.05) and serum HA ( P = 0.03), but not IL-1β, or IL-1Ra, decreased significantly in the IL-1Ra but not the placebo treated patients. Compared with placebo, IL-1α was borderline significantly different in the IL-1Ra treated group ( P = 0.06). Conclusions Administered within the first month following severe knee injury, IL-1Ra reduced knee pain and improved function over a 2-week interval. This promising proof of concept study provides a new paradigm for studies of acute joint injury and suggests that a larger follow-up study is warranted.</description><subject>Activities of Daily Living</subject><subject>Adult</subject><subject>Anterior cruciate ligament</subject><subject>Anterior Cruciate Ligament Injuries</subject><subject>Biomarkers</subject><subject>Biomarkers - metabolism</subject><subject>Clinical trial</subject><subject>Female</subject><subject>Humans</subject><subject>IL-1Ra</subject><subject>Injections, Intra-Articular</subject><subject>Interleukin 1 Receptor Antagonist Protein - administration & dosage</subject><subject>Interleukin 1 Receptor Antagonist Protein - therapeutic use</subject><subject>Joint injury</subject><subject>Knee Injuries - complications</subject><subject>Knee Injuries - diagnosis</subject><subject>Knee Injuries - drug therapy</subject><subject>Knee Injuries - rehabilitation</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Pain - drug therapy</subject><subject>Pain - etiology</subject><subject>Pilot Projects</subject><subject>Post-traumatic arthritis</subject><subject>Quality of Life</subject><subject>Recovery of Function</subject><subject>Rheumatology</subject><subject>Synovial Fluid - metabolism</subject><subject>Trauma Severity Indices</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1063-4584</issn><issn>1522-9653</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU-LFDEQxRtR3HX1C3iQ3NRDj5XqP9MjIsiw6sKgoCt4C9XV1ZLeTGdMuoXx7Ac3zawePHhKJbz3qPxelj3WsNKg6xfDavBMKwStVxpXAJs72bmuEPNNXRV30wx1kZdVU55lD2IcAKDQGu5nZ4i4LuoCz7Nfl30vPEXle2XHKRCFyfLsKKirnc4_kep9UMTzJIrGSYJNVw4zW0ovzn6jvYyTuhlFkn-Yw_GlIhVo7Pze_pROsU-p3rk0Hqzzk5qCJaeefdhep3UKxKp8_jC715OL8uj2vMi-vL283r7Pdx_fXW3f7HKuEKa8IpSi7lps27psqam5r0ts111VsSZCBOjrDQALQyFN0zDrCto1ARAJcHGRPT3lHoL_PkuczN5GFudoFD9Hs8GNRr2u6qTEk5KDjzFIbw7B7ikcjQazwDeDWeCbBb7RaBL8ZHpyGz-3e-n-Wv7QToJXJ4GkT_6wEkxkKyNLZ0MqwXTe_j__9T92dna0TO5GjhIHP4cx4TPaxGQwn5f6l_Z1AgMavxa_AadtqoE</recordid><startdate>20120401</startdate><enddate>20120401</enddate><creator>Kraus, V.B</creator><creator>Birmingham, J</creator><creator>Stabler, T.V</creator><creator>Feng, S</creator><creator>Taylor, D.C</creator><creator>Moorman, C.T</creator><creator>Garrett, W.E</creator><creator>Toth, A.P</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><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>7X8</scope></search><sort><creationdate>20120401</creationdate><title>Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254)</title><author>Kraus, V.B ; Birmingham, J ; Stabler, T.V ; Feng, S ; Taylor, D.C ; Moorman, C.T ; Garrett, W.E ; Toth, A.P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c520t-5a2e36db2bb64ba86cf642b7d55c1aa2200f6900cec03e888cc150b7a00aae0c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Activities of Daily Living</topic><topic>Adult</topic><topic>Anterior cruciate ligament</topic><topic>Anterior Cruciate Ligament Injuries</topic><topic>Biomarkers</topic><topic>Biomarkers - metabolism</topic><topic>Clinical trial</topic><topic>Female</topic><topic>Humans</topic><topic>IL-1Ra</topic><topic>Injections, Intra-Articular</topic><topic>Interleukin 1 Receptor Antagonist Protein - administration & dosage</topic><topic>Interleukin 1 Receptor Antagonist Protein - therapeutic use</topic><topic>Joint injury</topic><topic>Knee Injuries - complications</topic><topic>Knee Injuries - diagnosis</topic><topic>Knee Injuries - drug therapy</topic><topic>Knee Injuries - rehabilitation</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Pain - drug therapy</topic><topic>Pain - etiology</topic><topic>Pilot Projects</topic><topic>Post-traumatic arthritis</topic><topic>Quality of Life</topic><topic>Recovery of Function</topic><topic>Rheumatology</topic><topic>Synovial Fluid - metabolism</topic><topic>Trauma Severity Indices</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kraus, V.B</creatorcontrib><creatorcontrib>Birmingham, J</creatorcontrib><creatorcontrib>Stabler, T.V</creatorcontrib><creatorcontrib>Feng, S</creatorcontrib><creatorcontrib>Taylor, D.C</creatorcontrib><creatorcontrib>Moorman, C.T</creatorcontrib><creatorcontrib>Garrett, W.E</creatorcontrib><creatorcontrib>Toth, A.P</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Osteoarthritis and cartilage</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kraus, V.B</au><au>Birmingham, J</au><au>Stabler, T.V</au><au>Feng, S</au><au>Taylor, D.C</au><au>Moorman, C.T</au><au>Garrett, W.E</au><au>Toth, A.P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254)</atitle><jtitle>Osteoarthritis and cartilage</jtitle><addtitle>Osteoarthritis Cartilage</addtitle><date>2012-04-01</date><risdate>2012</risdate><volume>20</volume><issue>4</issue><spage>271</spage><epage>278</epage><pages>271-278</pages><issn>1063-4584</issn><eissn>1522-9653</eissn><abstract>Summary Objective To evaluate the clinical effectiveness of intraarticular IL-1 receptor antagonist (IL-1Ra) for anterior cruciate ligament (ACL) tear. Methods Eleven patients with acute ACL tear confirmed by magnetic resonance imaging (MRI) were randomized to receive a single intraarticular injection of IL-1Ra (anakinra 150 mg, n = 6) or equal volume of saline placebo (1 ml, n = 5). The double-blinded treatment was administered a mean 2 weeks after injury. Synovial fluid (SF) ( n = 9 patients) and sera (all patients) were available at baseline (prior to injection) and immediately prior to surgery (mean 35 days later) and analyzed for SF IL-1α, IL-1β, IL-1Ra and serum hyaluronan (HA), an indicator of synovial inflammation. The primary outcome, standardized Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, was obtained at 0 (baseline), 4, and 14 days after injection. Results Compared with placebo, the IL-1Ra group had substantially greater improvement in key outcomes over 14 days (KOOS pain P = 0.001; activities of daily living P = 0.0015; KOOS sports function P = 0.0026; KOOS quality of life (QOL) P = 0.0048; and total KOOS P < 0.0001). There were no adverse reactions in either group. SF IL-1α ( P = 0.05) and serum HA ( P = 0.03), but not IL-1β, or IL-1Ra, decreased significantly in the IL-1Ra but not the placebo treated patients. Compared with placebo, IL-1α was borderline significantly different in the IL-1Ra treated group ( P = 0.06). Conclusions Administered within the first month following severe knee injury, IL-1Ra reduced knee pain and improved function over a 2-week interval. This promising proof of concept study provides a new paradigm for studies of acute joint injury and suggests that a larger follow-up study is warranted.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>22273632</pmid><doi>10.1016/j.joca.2011.12.009</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Activities of Daily Living Adult Anterior cruciate ligament Anterior Cruciate Ligament Injuries Biomarkers Biomarkers - metabolism Clinical trial Female Humans IL-1Ra Injections, Intra-Articular Interleukin 1 Receptor Antagonist Protein - administration & dosage Interleukin 1 Receptor Antagonist Protein - therapeutic use Joint injury Knee Injuries - complications Knee Injuries - diagnosis Knee Injuries - drug therapy Knee Injuries - rehabilitation Magnetic Resonance Imaging Male Pain - drug therapy Pain - etiology Pilot Projects Post-traumatic arthritis Quality of Life Recovery of Function Rheumatology Synovial Fluid - metabolism Trauma Severity Indices Treatment Outcome Young Adult |
| title | Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254) |
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