Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study
Background: Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing. Purpose/Hyp...
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creator | Murray, Martha M. Kalish, Leslie A. Fleming, Braden C. Flutie, Brett Freiberger, Christina Henderson, Rachael N. Perrone, Gabriel S. Thurber, Laura G. Proffen, Benedikt L. Ecklund, Kirsten Kramer, Dennis E. Yen, Yi-Meng Micheli, Lyle J. |
description | Background:
Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing.
Purpose/Hypothesis:
The purpose of this study was to report the 12- and 24-month outcomes of patients who underwent the BEAR procedure compared with a nonrandomized concurrent control group who underwent ACL reconstruction (ACLR) with an autograft. We hypothesized that the BEAR group would have physical examination findings, patient-reported outcomes, and adverse events that were similar to those of the ACLR group.
Study Design:
Cohort study; Level of evidence, 2.
Methods:
Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes.
Results:
There were no graft or repair failures in the first 24 months after surgery. The IKDC subjective scores in both groups improved significantly from baseline (P < .0001) at 12 and 24 months, to 84.6 ± 17.2 in the ACLR group and to 91.7 ± 11.7 in the BEAR group. An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months; no patients in either group had C (abnormal) or D (severely abnormal) grades. Arthrometer testing demonstrated mean side-to-side differences in AP laxity that were similar in the 2 groups at 24 months (BEAR, 1.94 ± 2.08 mm; ACLR, 3.14 ± 2.66 mm). Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001).
Conclusion:
In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. BEAR may result in knee stability and patient-reported outcomes at 2 years sufficient to warrant longer term studies of efficacy in larger groups of patients. |
doi_str_mv | 10.1177/2325967118824356 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6431773</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_2325967118824356</sage_id><sourcerecordid>2313783273</sourcerecordid><originalsourceid>FETCH-LOGICAL-c462t-ab761a7637f8abcba9bf79652460473abd35961bd3c71a8f74bde9948685a3f63</originalsourceid><addsrcrecordid>eNp1UU1P3DAUtKqighbuPSFLXHox-COxEw6VYMUC0kpILT30UFkvibN4ldhbO2m1_x4vS_lYqb48azxv3hsPQp8ZPWVMqTMueF5KxVhR8Ezk8gM62EBkg318c99HRzEuaTpFzkqhPqF9QUsuFM8P0K_LYJuFIVfuAVxtGnzhBhOsD3gaxtrCYPDcLqA3bsDfzApsOMf3fz35aSAkII7dELFvMeCZDXEg1pGbsQeHvw9jsz5Eey100Rw91wn6Mbu6n96Q-d317fRiTupM8oFApSQDJYVqC6jqCsqqVaXMeSZppgRUjUhOWSq1YlC0KqsaU5ZZIYscRCvFBH3d6q7GqjdNnbYN0OlVsD2EtfZg9fsXZx_0wv_RMhPpK0US-PIsEPzv0cRB9zbWpuvAGT9GzTmlSsoyp4l6skNd-jG4ZE9zwYQqBH8SpFtWHXyMwbQvyzCqN_Hp3fhSy_FbEy8N_8JKBLIlRFiY16n_FXwE8xKhWA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2313783273</pqid></control><display><type>article</type><title>Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study</title><source>DOAJ Directory of Open Access Journals</source><source>Sage Journals GOLD Open Access 2024</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>Murray, Martha M. ; Kalish, Leslie A. ; Fleming, Braden C. ; Flutie, Brett ; Freiberger, Christina ; Henderson, Rachael N. ; Perrone, Gabriel S. ; Thurber, Laura G. ; Proffen, Benedikt L. ; Ecklund, Kirsten ; Kramer, Dennis E. ; Yen, Yi-Meng ; Micheli, Lyle J.</creator><creatorcontrib>Murray, Martha M. ; Kalish, Leslie A. ; Fleming, Braden C. ; Flutie, Brett ; Freiberger, Christina ; Henderson, Rachael N. ; Perrone, Gabriel S. ; Thurber, Laura G. ; Proffen, Benedikt L. ; Ecklund, Kirsten ; Kramer, Dennis E. ; Yen, Yi-Meng ; Micheli, Lyle J. ; BEAR Trial Team ; BEAR Trial Team</creatorcontrib><description>Background:
Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing.
Purpose/Hypothesis:
The purpose of this study was to report the 12- and 24-month outcomes of patients who underwent the BEAR procedure compared with a nonrandomized concurrent control group who underwent ACL reconstruction (ACLR) with an autograft. We hypothesized that the BEAR group would have physical examination findings, patient-reported outcomes, and adverse events that were similar to those of the ACLR group.
Study Design:
Cohort study; Level of evidence, 2.
Methods:
Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes.
Results:
There were no graft or repair failures in the first 24 months after surgery. The IKDC subjective scores in both groups improved significantly from baseline (P < .0001) at 12 and 24 months, to 84.6 ± 17.2 in the ACLR group and to 91.7 ± 11.7 in the BEAR group. An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months; no patients in either group had C (abnormal) or D (severely abnormal) grades. Arthrometer testing demonstrated mean side-to-side differences in AP laxity that were similar in the 2 groups at 24 months (BEAR, 1.94 ± 2.08 mm; ACLR, 3.14 ± 2.66 mm). Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001).
Conclusion:
In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. BEAR may result in knee stability and patient-reported outcomes at 2 years sufficient to warrant longer term studies of efficacy in larger groups of patients.</description><identifier>ISSN: 2325-9671</identifier><identifier>EISSN: 2325-9671</identifier><identifier>DOI: 10.1177/2325967118824356</identifier><identifier>PMID: 30923725</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Knee ; Ligaments ; Orthopedics ; Patients ; Sports medicine</subject><ispartof>Orthopaedic journal of sports medicine, 2019-03, Vol.7 (3), p.2325967118824356-2325967118824356</ispartof><rights>The Author(s) 2019</rights><rights>The Author(s) 2019. This work is licensed under the Creative Commons Attribution – Non-Commercial – No Derivatives License http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2019 2019 SAGE Publications</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c462t-ab761a7637f8abcba9bf79652460473abd35961bd3c71a8f74bde9948685a3f63</citedby><cites>FETCH-LOGICAL-c462t-ab761a7637f8abcba9bf79652460473abd35961bd3c71a8f74bde9948685a3f63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6431773/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6431773/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,21970,27857,27928,27929,44949,45337,53795,53797</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30923725$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Murray, Martha M.</creatorcontrib><creatorcontrib>Kalish, Leslie A.</creatorcontrib><creatorcontrib>Fleming, Braden C.</creatorcontrib><creatorcontrib>Flutie, Brett</creatorcontrib><creatorcontrib>Freiberger, Christina</creatorcontrib><creatorcontrib>Henderson, Rachael N.</creatorcontrib><creatorcontrib>Perrone, Gabriel S.</creatorcontrib><creatorcontrib>Thurber, Laura G.</creatorcontrib><creatorcontrib>Proffen, Benedikt L.</creatorcontrib><creatorcontrib>Ecklund, Kirsten</creatorcontrib><creatorcontrib>Kramer, Dennis E.</creatorcontrib><creatorcontrib>Yen, Yi-Meng</creatorcontrib><creatorcontrib>Micheli, Lyle J.</creatorcontrib><creatorcontrib>BEAR Trial Team</creatorcontrib><creatorcontrib>BEAR Trial Team</creatorcontrib><title>Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study</title><title>Orthopaedic journal of sports medicine</title><addtitle>Orthop J Sports Med</addtitle><description>Background:
Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing.
Purpose/Hypothesis:
The purpose of this study was to report the 12- and 24-month outcomes of patients who underwent the BEAR procedure compared with a nonrandomized concurrent control group who underwent ACL reconstruction (ACLR) with an autograft. We hypothesized that the BEAR group would have physical examination findings, patient-reported outcomes, and adverse events that were similar to those of the ACLR group.
Study Design:
Cohort study; Level of evidence, 2.
Methods:
Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes.
Results:
There were no graft or repair failures in the first 24 months after surgery. The IKDC subjective scores in both groups improved significantly from baseline (P < .0001) at 12 and 24 months, to 84.6 ± 17.2 in the ACLR group and to 91.7 ± 11.7 in the BEAR group. An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months; no patients in either group had C (abnormal) or D (severely abnormal) grades. Arthrometer testing demonstrated mean side-to-side differences in AP laxity that were similar in the 2 groups at 24 months (BEAR, 1.94 ± 2.08 mm; ACLR, 3.14 ± 2.66 mm). Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001).
Conclusion:
In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. BEAR may result in knee stability and patient-reported outcomes at 2 years sufficient to warrant longer term studies of efficacy in larger groups of patients.</description><subject>Knee</subject><subject>Ligaments</subject><subject>Orthopedics</subject><subject>Patients</subject><subject>Sports medicine</subject><issn>2325-9671</issn><issn>2325-9671</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>AFRWT</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNp1UU1P3DAUtKqighbuPSFLXHox-COxEw6VYMUC0kpILT30UFkvibN4ldhbO2m1_x4vS_lYqb48azxv3hsPQp8ZPWVMqTMueF5KxVhR8Ezk8gM62EBkg318c99HRzEuaTpFzkqhPqF9QUsuFM8P0K_LYJuFIVfuAVxtGnzhBhOsD3gaxtrCYPDcLqA3bsDfzApsOMf3fz35aSAkII7dELFvMeCZDXEg1pGbsQeHvw9jsz5Eey100Rw91wn6Mbu6n96Q-d317fRiTupM8oFApSQDJYVqC6jqCsqqVaXMeSZppgRUjUhOWSq1YlC0KqsaU5ZZIYscRCvFBH3d6q7GqjdNnbYN0OlVsD2EtfZg9fsXZx_0wv_RMhPpK0US-PIsEPzv0cRB9zbWpuvAGT9GzTmlSsoyp4l6skNd-jG4ZE9zwYQqBH8SpFtWHXyMwbQvyzCqN_Hp3fhSy_FbEy8N_8JKBLIlRFiY16n_FXwE8xKhWA</recordid><startdate>20190301</startdate><enddate>20190301</enddate><creator>Murray, Martha M.</creator><creator>Kalish, Leslie A.</creator><creator>Fleming, Braden C.</creator><creator>Flutie, Brett</creator><creator>Freiberger, Christina</creator><creator>Henderson, Rachael N.</creator><creator>Perrone, Gabriel S.</creator><creator>Thurber, Laura G.</creator><creator>Proffen, Benedikt L.</creator><creator>Ecklund, Kirsten</creator><creator>Kramer, Dennis E.</creator><creator>Yen, Yi-Meng</creator><creator>Micheli, Lyle J.</creator><general>SAGE Publications</general><general>Sage Publications Ltd</general><scope>AFRWT</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20190301</creationdate><title>Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study</title><author>Murray, Martha M. ; Kalish, Leslie A. ; Fleming, Braden C. ; Flutie, Brett ; Freiberger, Christina ; Henderson, Rachael N. ; Perrone, Gabriel S. ; Thurber, Laura G. ; Proffen, Benedikt L. ; Ecklund, Kirsten ; Kramer, Dennis E. ; Yen, Yi-Meng ; Micheli, Lyle J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c462t-ab761a7637f8abcba9bf79652460473abd35961bd3c71a8f74bde9948685a3f63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Knee</topic><topic>Ligaments</topic><topic>Orthopedics</topic><topic>Patients</topic><topic>Sports medicine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Murray, Martha M.</creatorcontrib><creatorcontrib>Kalish, Leslie A.</creatorcontrib><creatorcontrib>Fleming, Braden C.</creatorcontrib><creatorcontrib>Flutie, Brett</creatorcontrib><creatorcontrib>Freiberger, Christina</creatorcontrib><creatorcontrib>Henderson, Rachael N.</creatorcontrib><creatorcontrib>Perrone, Gabriel S.</creatorcontrib><creatorcontrib>Thurber, Laura G.</creatorcontrib><creatorcontrib>Proffen, Benedikt L.</creatorcontrib><creatorcontrib>Ecklund, Kirsten</creatorcontrib><creatorcontrib>Kramer, Dennis E.</creatorcontrib><creatorcontrib>Yen, Yi-Meng</creatorcontrib><creatorcontrib>Micheli, Lyle J.</creatorcontrib><creatorcontrib>BEAR Trial Team</creatorcontrib><creatorcontrib>BEAR Trial Team</creatorcontrib><collection>Sage Journals GOLD Open Access 2024</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</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 Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</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>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Orthopaedic journal of sports medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Murray, Martha M.</au><au>Kalish, Leslie A.</au><au>Fleming, Braden C.</au><au>Flutie, Brett</au><au>Freiberger, Christina</au><au>Henderson, Rachael N.</au><au>Perrone, Gabriel S.</au><au>Thurber, Laura G.</au><au>Proffen, Benedikt L.</au><au>Ecklund, Kirsten</au><au>Kramer, Dennis E.</au><au>Yen, Yi-Meng</au><au>Micheli, Lyle J.</au><aucorp>BEAR Trial Team</aucorp><aucorp>BEAR Trial Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study</atitle><jtitle>Orthopaedic journal of sports medicine</jtitle><addtitle>Orthop J Sports Med</addtitle><date>2019-03-01</date><risdate>2019</risdate><volume>7</volume><issue>3</issue><spage>2325967118824356</spage><epage>2325967118824356</epage><pages>2325967118824356-2325967118824356</pages><issn>2325-9671</issn><eissn>2325-9671</eissn><abstract>Background:
Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing.
Purpose/Hypothesis:
The purpose of this study was to report the 12- and 24-month outcomes of patients who underwent the BEAR procedure compared with a nonrandomized concurrent control group who underwent ACL reconstruction (ACLR) with an autograft. We hypothesized that the BEAR group would have physical examination findings, patient-reported outcomes, and adverse events that were similar to those of the ACLR group.
Study Design:
Cohort study; Level of evidence, 2.
Methods:
Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes.
Results:
There were no graft or repair failures in the first 24 months after surgery. The IKDC subjective scores in both groups improved significantly from baseline (P < .0001) at 12 and 24 months, to 84.6 ± 17.2 in the ACLR group and to 91.7 ± 11.7 in the BEAR group. An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months; no patients in either group had C (abnormal) or D (severely abnormal) grades. Arthrometer testing demonstrated mean side-to-side differences in AP laxity that were similar in the 2 groups at 24 months (BEAR, 1.94 ± 2.08 mm; ACLR, 3.14 ± 2.66 mm). Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001).
Conclusion:
In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. BEAR may result in knee stability and patient-reported outcomes at 2 years sufficient to warrant longer term studies of efficacy in larger groups of patients.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>30923725</pmid><doi>10.1177/2325967118824356</doi><oa>free_for_read</oa></addata></record> |
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subjects | Knee Ligaments Orthopedics Patients Sports medicine |
title | Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study |
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