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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

Snow, Martyn; Middleton, Lee; Mehta, Samir; Roberts, Andrew; Gray, Richard; Richardson, James; Kuiper, Jan Herman; Smith, Anthony; White, Steve; Roberts, Simon; Griffiths, David; Mohammed, Aslam; Moholkar, Kirti; Ashraf, Tanweer; Green, Marcus; Hutchinson, James; Bhullar, Tony; Chitnis, Sanjeev; Shaw, Andrew; van Niekerk, Louw; Hui, Anthony; Drogset, Jon Olav; Knutsen, Gunnar; McNicholas, Mike; Bowditch, Mark; Johnson, David; Turner, Philip; Chugh, Sanjiv; Hunt, Neil; Ali, Salman; Palmer, Simon; Perry, Andrew; Davidson, Alastair; Hill, Peter; Deo, Sunny; Satish, Venkat; Radford, Michael; Langstaff, Ron; Houlihan-Burne, David; Spicer, Dominic; Phaltankar, Padman; Hegab, Ahmed; Marsh, David; Cannon, Steve; Briggs, Tim; Pollock, Rob; Carrington, Richard; Skinner, John; Bentley, George; Price, Andrew; Schranz, Peter; Mandalia, Vipul; O’Brien, Shaun

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 Thumbnail


Authors

Lee Middleton

Samir Mehta

Andrew Roberts

Richard Gray

James Richardson

Anthony Smith

Steve White

Simon Roberts

David Griffiths

Aslam Mohammed

Kirti Moholkar

Tanweer Ashraf

Marcus Green

James Hutchinson

Tony Bhullar

Sanjeev Chitnis

Andrew Shaw

Louw van Niekerk

Anthony Hui

Jon Olav Drogset

Gunnar Knutsen

Mike McNicholas

Mark Bowditch

David Johnson

Philip Turner

Sanjiv Chugh

Neil Hunt

Salman Ali

Simon Palmer

Andrew Perry

Alastair Davidson

Peter Hill

Sunny Deo

Venkat Satish

Michael Radford

Ron Langstaff

David Houlihan-Burne

Dominic Spicer

Padman Phaltankar

Ahmed Hegab

David Marsh

Steve Cannon

Tim Briggs

Rob Pollock

Richard Carrington

John Skinner

George Bentley

Andrew Price

Peter Schranz

Vipul Mandalia

Shaun O’Brien



Abstract

BACKGROUND: 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. PURPOSE: 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. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: 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. RESULTS: 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). CONCLUSION: 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. REGISTRATION: International Standard Randomised Controlled Trial Number: 48911177.

Journal Article Type Article
Acceptance Date Jan 20, 2023
Online Publication Date Jan 20, 2023
Publication Date Jan 20, 2023
Publicly Available Date May 30, 2023
Journal The American Journal of Sports Medicine
Print ISSN 0363-5465
Publisher SAGE Publications
Volume 51
Issue 2
Pages 367-378
DOI https://doi.org/10.1177/03635465221141907
Keywords Physical Therapy, Sports Therapy and Rehabilitation, Orthopedics and Sports Medicine
Publisher URL https://journals.sagepub.com/doi/10.1177/03635465221141907

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