{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:35:30Z","timestamp":1792787730533,"version":"4.5.0"},"reference-count":33,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T00:00:00Z","timestamp":1776297600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Cartiheal Ltd"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Am J Sports Med"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Chondral\/osteochondral knee lesions are commonly encountered and often associated with progression of osteoarthritis (OA). Nevertheless, knee repair trials have traditionally excluded patients with concurrent mild to moderate OA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>To compare the clinical and safety outcomes of knee repair with an aragonite-based osteochondral implant with outcomes of surgical standard of care (SSOC) in patients with chondral\/osteochondral knee lesions, including those with mild to moderate OA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design:<\/jats:title>\n                    <jats:p>Randomized controlled trial; Level of evidence, 1.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      Investigators at 26 centers across 8 countries enrolled adult patients (21-75 years of age) with \u22643 cartilage defects of International Cartilage Regeneration &amp; Joint Preservation Society grade \u22653a located on the femoral condyles and\/or trochlea, total treatable area 1 to 7 cm\n                      <jats:sup>2<\/jats:sup>\n                      , bony defect depth \u22648 mm, and Kellgren-Lawrence knee OA score of 0 to 3. Patients were randomized 2:1 to receive an aragonite-based implant or SSOC (arthroscopic debridement or microfracture) and followed for 5 years. The primary endpoint was improvement in overall Knee injury and Osteoarthritis Outcome Score (KOOS). Secondary endpoints included percentage of responders (minimum overall KOOS improvement \u2265 30 points), patient-reported outcomes (KOOS subscale values and International Knee Documentation Committee subjective score), treatment failure (ie, need for any secondary treatment), and treatment-emergent adverse events. A covariate analysis compared primary\/secondary outcomes between patients with no to minimal and mild to moderate OA.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      In total, 167 patients underwent knee repair with the study implant and 84 with SSOC, with follow-up compliance rates of 88.4% and 83.1%, respectively, at 5 years. The mean baseline overall KOOS values were comparable between the implant (41.2 \u00b1 13.1) and SSOC (41.7 \u00b1 12.4) groups. By the final follow-up, improvement was significantly greater for the implant group (81.0 \u00b1 23.0 vs 59.1 \u00b1 25.2; 22.6-point difference; 95% CI, 16.6-28.7). The overall KOOS responder rate was 74.7% in the implant group and 29.6% in the SSOC group. The implant group experienced significantly superior outcomes between baseline and the final follow-up for all secondary patient-reported outcome measures. Treatment failure rate was significantly higher with SSOC than the implant (35.7% vs 15.0%;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .001). Among patients with mild to moderate OA, the implant group exhibited a higher overall KOOS responder rate (74.6% vs 36.2%) and lower failure rate (13.2% vs 40.7%;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .001) than the SSOC group.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The results confirmed that the aragonite-based scaffold is both safe and superior to SSOC in improving clinical outcomes at up to 5 years\u2019 evaluation, as well as in patients with mild to moderate OA.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03635465261437781","type":"journal-article","created":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T05:16:21Z","timestamp":1776402981000},"page":"1376-1385","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Five-Year Follow-up of a Multicenter Randomized Controlled Trial Comparing an Aragonite-Based Scaffold With Microfracture and Debridement for Chondral and Osteochondral Knee Lesions"],"prefix":"10.1177","volume":"54","author":[{"given":"Nir","family":"Altschuler","sequence":"first","affiliation":[{"name":"Altschuler Consulting, LLC, Kfar Saba, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9709-6461","authenticated-orcid":false,"given":"Kenneth R.","family":"Zaslav","sequence":"additional","affiliation":[{"name":"Lennox Hill Hospital\u2013Northwell Health Orthopedic Institute, New York, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9807-0271","authenticated-orcid":false,"given":"Berardo","family":"Di Matteo","sequence":"additional","affiliation":[{"name":"IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy"},{"name":"Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth L.","family":"Sherman","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Stanford University, Stanford, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas H.","family":"Gomoll","sequence":"additional","affiliation":[{"name":"Hospital for Special Surgery\u2013Orthopedic Surgery and Sports Medicine, New York, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott A.","family":"Hacker","sequence":"additional","affiliation":[{"name":"Grossmont Orthopedic Medical Group, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Verdonk","sequence":"additional","affiliation":[{"name":"Orthoca, Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Dulic","sequence":"additional","affiliation":[{"name":"University of Novi Sad, Novi Sad, Serbia"},{"name":"University Clinical Center of Vojvodina, Novi Sad, Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenel M.","family":"Patrascu","sequence":"additional","affiliation":[{"name":"Victor Babe\u015f Timisoara University of Medicine and Pharmacy, Timisoara, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew S.","family":"Levy","sequence":"additional","affiliation":[{"name":"Center for Advanced Sports Medicine, Knee and Shoulder, Millburn, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2517-4069","authenticated-orcid":false,"given":"Dror","family":"Robinson","sequence":"additional","affiliation":[{"name":"Robinson Clinic, Bat Yam, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizaveta","family":"Kon","sequence":"additional","affiliation":[{"name":"IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy"},{"name":"Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,4,16]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.msec.2018.10.039"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1177\/03635465231151252"},{"issue":"1","key":"e_1_3_3_4_2","first-page":"119","article-title":"Comparison of different knee implants used on patients with osteoarthritis. 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