A randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the knee
<strong>Background:<br></strong> There are limited randomized controlled trials with long-term outcomes comparing autologous chondrocyte implantation (ACI) versus alternative forms of surgical cartilage management within the knee. <br><strong>Purpose:<br></stro...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Other Authors: | |
| Format: | Journal article |
| Language: | English |
| Published: |
SAGE Publications
2023
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| _version_ | 1797108962971090944 |
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| author | Snow, M Middleton, L Mehta, S Roberts, A Gray, R Richardson, J Kuiper, JH Price, A Smith, A White, S Roberts, S Griffiths, D Mohammed, A Moholkar, K Ashraf, T Green, M Hutchinson, J Bhullar, T Chitnis, S Shaw, A van Niekerk, L Hui, A Drogset, JO Knutsen, G McNicholas, M Bowditch, M Johnson, D Turner, P Chugh, S Hunt, N Ali, S Palmer, S Perry, A Davidson, A Hill, P Deo, S Satish, V Radford, M Langstaff, R Houlihan-Burne, D Spicer, D Phaltankar, P Hegab, A Marsh, D Cannon, S Briggs, T Pollock, R Carrington, R Skinner, J Bentley, G |
| author2 | ACTIVE Consortium |
| author_facet | ACTIVE Consortium Snow, M Middleton, L Mehta, S Roberts, A Gray, R Richardson, J Kuiper, JH Price, A Smith, A White, S Roberts, S Griffiths, D Mohammed, A Moholkar, K Ashraf, T Green, M Hutchinson, J Bhullar, T Chitnis, S Shaw, A van Niekerk, L Hui, A Drogset, JO Knutsen, G McNicholas, M Bowditch, M Johnson, D Turner, P Chugh, S Hunt, N Ali, S Palmer, S Perry, A Davidson, A Hill, P Deo, S Satish, V Radford, M Langstaff, R Houlihan-Burne, D Spicer, D Phaltankar, P Hegab, A Marsh, D Cannon, S Briggs, T Pollock, R Carrington, R Skinner, J Bentley, G |
| author_sort | Snow, M |
| collection | OXFORD |
| description | <strong>Background:<br></strong>
There are limited randomized controlled trials with long-term outcomes comparing autologous chondrocyte implantation (ACI) versus alternative forms of surgical cartilage management within the knee.
<br><strong>Purpose:<br></strong>
To determine at 5 years after surgery whether ACI was superior to alternative forms of cartilage management in patients after a failed previous treatment for chondral or osteochondral defects in the knee.
<br><strong>Study Design:<br></strong>
Randomized controlled trial; Level of evidence, 1.
<br><strong>Methods:<br></strong>
In total, 390 participants were randomly assigned to receive either ACI or alternative management. Patients aged 18 to 55 years with one or two symptomatic cartilage defects who had failed 1 previous therapeutic surgical procedure in excess of 6 months prior were included. Dual primary outcome measures were used: (1) patient-completed Lysholm knee score and (2) time from surgery to cessation of treatment benefit. Secondary outcome measures included International Knee Documentation Committee and Cincinnati Knee Rating System scores, as well as number of serious adverse events. Analysis was performed on an intention-to-treat basis.
<br><strong>Results:<br></strong>
Lysholm scores were improved by 1 year in both groups (15.4 points [95% CI, 11.9 to 18.8] and 15.2 points [95% CI, 11.6 to 18.9]) for ACI and alternative, with this improvement sustained over the duration of the trial. However, no evidence of a difference was found between the groups at 5 years (2.9 points; 95% CI, −1.8 to 7.5; P = .46). Approximately half of the participants (55%; 95% CI, 47% to 64% with ACI) were still experiencing benefit at 5 years, with time to cessation of treatment benefit similar in both groups (hazard ratio, 0.97; 95% CI, 0.72 to 1.32; P > .99). There was a differential effect on Lysholm scores in patients without previous marrow stimulation compared with those with marrow stimulation (P = .03; 6.4 points in favor of ACI; 95% CI, −0.4 to 13.1). More participants experienced a serious adverse event with ACI (P = .02).
<br><strong>Conclusion:<br></strong>
Over 5 years, there was no evidence of a difference in Lysholm scores between ACI and alternative management in patients who had previously failed treatment. Previous marrow stimulation had a detrimental effect on the outcome of ACI.
<br><strong>Registration:<br></strong>
International Standard Randomised Controlled Trial Number: 48911177 |
| first_indexed | 2024-03-07T07:35:19Z |
| format | Journal article |
| id | oxford-uuid:b5315ac0-39ae-45e3-96bf-bb1ed1488710 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:35:19Z |
| publishDate | 2023 |
| publisher | SAGE Publications |
| record_format | dspace |
| spelling | oxford-uuid:b5315ac0-39ae-45e3-96bf-bb1ed14887102023-02-28T12:29:36ZA randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the kneeJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:b5315ac0-39ae-45e3-96bf-bb1ed1488710EnglishSymplectic ElementsSAGE Publications2023Snow, MMiddleton, LMehta, SRoberts, AGray, RRichardson, JKuiper, JHPrice, ASmith, AWhite, SRoberts, SGriffiths, DMohammed, AMoholkar, KAshraf, TGreen, MHutchinson, JBhullar, TChitnis, SShaw, Avan Niekerk, LHui, ADrogset, JOKnutsen, GMcNicholas, MBowditch, MJohnson, DTurner, PChugh, SHunt, NAli, SPalmer, SPerry, ADavidson, AHill, PDeo, SSatish, VRadford, MLangstaff, RHoulihan-Burne, DSpicer, DPhaltankar, PHegab, AMarsh, DCannon, SBriggs, TPollock, RCarrington, RSkinner, JBentley, GACTIVE Consortium<strong>Background:<br></strong> There are limited randomized controlled trials with long-term outcomes comparing autologous chondrocyte implantation (ACI) versus alternative forms of surgical cartilage management within the knee. <br><strong>Purpose:<br></strong> To determine at 5 years after surgery whether ACI was superior to alternative forms of cartilage management in patients after a failed previous treatment for chondral or osteochondral defects in the knee. <br><strong>Study Design:<br></strong> Randomized controlled trial; Level of evidence, 1. <br><strong>Methods:<br></strong> In total, 390 participants were randomly assigned to receive either ACI or alternative management. Patients aged 18 to 55 years with one or two symptomatic cartilage defects who had failed 1 previous therapeutic surgical procedure in excess of 6 months prior were included. Dual primary outcome measures were used: (1) patient-completed Lysholm knee score and (2) time from surgery to cessation of treatment benefit. Secondary outcome measures included International Knee Documentation Committee and Cincinnati Knee Rating System scores, as well as number of serious adverse events. Analysis was performed on an intention-to-treat basis. <br><strong>Results:<br></strong> Lysholm scores were improved by 1 year in both groups (15.4 points [95% CI, 11.9 to 18.8] and 15.2 points [95% CI, 11.6 to 18.9]) for ACI and alternative, with this improvement sustained over the duration of the trial. However, no evidence of a difference was found between the groups at 5 years (2.9 points; 95% CI, −1.8 to 7.5; P = .46). Approximately half of the participants (55%; 95% CI, 47% to 64% with ACI) were still experiencing benefit at 5 years, with time to cessation of treatment benefit similar in both groups (hazard ratio, 0.97; 95% CI, 0.72 to 1.32; P > .99). There was a differential effect on Lysholm scores in patients without previous marrow stimulation compared with those with marrow stimulation (P = .03; 6.4 points in favor of ACI; 95% CI, −0.4 to 13.1). More participants experienced a serious adverse event with ACI (P = .02). <br><strong>Conclusion:<br></strong> Over 5 years, there was no evidence of a difference in Lysholm scores between ACI and alternative management in patients who had previously failed treatment. Previous marrow stimulation had a detrimental effect on the outcome of ACI. <br><strong>Registration:<br></strong> International Standard Randomised Controlled Trial Number: 48911177 |
| spellingShingle | Snow, M Middleton, L Mehta, S Roberts, A Gray, R Richardson, J Kuiper, JH Price, A Smith, A White, S Roberts, S Griffiths, D Mohammed, A Moholkar, K Ashraf, T Green, M Hutchinson, J Bhullar, T Chitnis, S Shaw, A van Niekerk, L Hui, A Drogset, JO Knutsen, G McNicholas, M Bowditch, M Johnson, D Turner, P Chugh, S Hunt, N Ali, S Palmer, S Perry, A Davidson, A Hill, P Deo, S Satish, V Radford, M Langstaff, R Houlihan-Burne, D Spicer, D Phaltankar, P Hegab, A Marsh, D Cannon, S Briggs, T Pollock, R Carrington, R Skinner, J Bentley, G A randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the knee |
| title | A randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the knee |
| title_full | A randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the knee |
| title_fullStr | A randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the knee |
| title_full_unstemmed | A randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the knee |
| title_short | A randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the knee |
| title_sort | randomized trial of autologous chondrocyte implantation versus alternative forms of surgical cartilage management in patients with a failed primary treatment for chondral or osteochondral defects in the knee |
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randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT middletonl randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT mehtas randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT robertsa randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT grayr randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT richardsonj randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT kuiperjh randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT pricea randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT smitha randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT whites randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT robertss randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT griffithsd randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT mohammeda randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT moholkark randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT ashraft randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT greenm randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT hutchinsonj randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT bhullart randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT chitniss randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT shawa randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT vanniekerkl randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT huia randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT drogsetjo randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT knutseng randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT mcnicholasm randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT bowditchm randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT johnsond randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT turnerp randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT chughs randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT huntn randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT alis randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT palmers randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT perrya randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT davidsona randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT hillp randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT deos randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT satishv randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT radfordm randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT langstaffr randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT houlihanburned randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT spicerd randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT phaltankarp randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT hegaba randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT marshd randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT cannons randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT briggst randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT pollockr randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT carringtonr randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT skinnerj randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee AT bentleyg randomizedtrialofautologouschondrocyteimplantationversusalternativeformsofsurgicalcartilagemanagementinpatientswithafailedprimarytreatmentforchondralorosteochondraldefectsintheknee |