Abstract
Purpose
Quantitative magnetic resonance imaging (qMRI) has been used to determine the failure properties of ACL grafts and native ACL repairs and/or restorations. How these properties relate to future clinical, functional, and patient-reported outcomes remain unknown. The study objective was to investigate the relationship between non-contemporaneous qMRI measures and traditional outcome measures following Bridge-Enhanced ACL Restoration (BEAR). It was hypothesized that qMRI parameters at 6 months would be associated with clinical, functional, and/or patient-reported outcomes at 6 months, 24 months, and changes from 6 to 24 months post-surgery.
Methods
Data of BEAR patients (n = 65) from a randomized control trial of BEAR versus ACL reconstruction (BEAR II Trial; NCT02664545) were utilized retrospectively for the present analysis. Images were acquired using the Constructive Interference in Steady State (CISS) sequence at 6 months post-surgery. Single-leg hop test ratios, arthrometric knee laxity values, and International Knee Documentation Committee (IKDC) subjective scores were determined at 6 and 24 months post-surgery. The associations between traditional outcomes and MRI measures of normalized signal intensity, mean cross-sectional area (CSA), volume, and estimated failure load of the healing ACL were evaluated based on bivariate correlations and multivariable regression analyses, which considered the potential effects of age, sex, and body mass index.
Results
CSA (r = 0.44, p = 0.01), volume (r = 0.44, p = 0.01), and estimated failure load (r = 0.48, p = 0.01) at 6 months were predictive of the change in single-leg hop ratio from 6 to 24 months in bivariate analysis. CSA (βstandardized = 0.42, p = 0.01), volume (βstandardized = 0.42, p = 0.01), and estimated failure load (βstandardized = 0.48, p = 0.01) remained significant predictors when considering the demographic variables. No significant associations were observed between MRI variables and either knee laxity or IKDC when adjusting for demographic variables. Signal intensity was also not significant at any timepoint.
Conclusion
The qMRI-based measures of CSA, volume, and estimated failure load were predictive of a positive functional outcome trajectory from 6 to 24 months post-surgery. These variables measured using qMRI at 6 months post-surgery could serve as prospective markers of the functional outcome trajectory from 6 to 24 months post-surgery, aiding in rehabilitation programming and return-to-sport decisions to improve surgical outcomes and reduce the risk of reinjury.
Level of evidence
Level II.
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Abbreviations
- ACL:
-
Anterior cruciate ligament
- ACLR:
-
Anterior cruciate ligament reconstruction
- BEAR:
-
Bridge-enhanced anterior cruciate ligament restoration
- BMI:
-
Body mass index
- CISS:
-
Constructive interference in steady state
- CSA:
-
Cross-sectional area
- IKDC:
-
International knee documentation committee
- KOOS:
-
Knee injury and osteoarthritis outcome score
- SI:
-
Signal intensity
- qMRI:
-
Quantitative magnetic resonance imaging
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Acknowledgements
This work was supported by the BEAR Trial Team. We would like to thank the following: Benedikt Proffen, Nicholas Sant, Gabriela Portilla, Ryan Sanborn, Christina Freiberger, Rachael Henderson, Samuel Barnett, Yi-Meng Yen, Lyle Micheli.
Funding
Translational Research Program at Boston Children’s Hospital, the Children’s Hospital Orthopaedic Surgery Foundation, the Children’s Hospital Sports Medicine Foundation, the Football Players Health Study at Harvard University, the National Institutes of Health (R01-AR065462, R01-AR056834 and P30-GM122732), and the Lucy Lippitt Endowment of Brown University.
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SWF and GJB performed statistical analyses. AMK performed image processing. MMM, KE, DEK, and BEAR Trial Team designed and collected the BEAR clinical trial data. SWF, MMM, BCF, AMK conceived and designed the study. SWF, AMK and BCF drafted the manuscript. All authors read and approved the final manuscript. This study was funded by the Translational Research Program at Boston Children’s Hospital, the Children’s Hospital Orthopaedic Surgery Foundation, the Children’s Hospital Sports Medicine Foundation, the Football Players Health Study at Harvard University, the National Institutes of Health (R01-AR065462, R01-AR056834 and P30-GM122732), and the Lucy Lippitt Endowment of Brown University.
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MMM, AMK, BCF (Miach Orthopaedics); BCF and AMK (AJSM). One or more of the authors has declared the following potential conflict of interest: MMM is a founder and equity holder in Miach Orthopaedics, Inc, which was formed to upscale production of the BEAR scaffold. MMM maintained a conflict-of-interest management plan that was approved by Boston Children’s Hospital and Harvard Medical School during the conduct of the trial, with oversight by both conflict-of-interest committees and the institutional review board of Boston Children’s Hospital, as well as the US Food and Drug Administration. AMK is a paid consultant of Miach Orthopaedics. DEK is a paid consultant for Miach Orthopaedics, Johnson & Johnson, and receives educational support from Kairos Surgical. BCF is an associate editor for The American Journal of Sports Medicine, a founder of Miach Orthopaedics, and the spouse of MMM who has the added conflicts. A conflict-of-interest management plan for BCF was implemented by Rhode Island Hospital during the course of this study.
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Informed consent was obtained following IRB approval (IRB P00021470). Author contributions: SWF and GJB performed statistical analyses. AMK performed image processing. MMM, KE, DEK, and BEAR Trial Team designed and collected the BEAR clinical trial data. SWF, MMM, BCF, AMK conceived and designed the study. SWF, AMK and BCF drafted the manuscript. All authors read and approved the final manuscript.
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BEAR Trial Team: Benedikt Proffen, Nicholas Sant, Gabriela Portilla, Ryan Sanborn, Christina Freiberger, Rachael Henderson, Samuel Barnett, Yi-Meng Yen, Lyle Micheli
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Flannery, S.W., Murray, M.M., Badger, G.J. et al. Early MRI-based quantitative outcomes are associated with a positive functional performance trajectory from 6 to 24 months post-ACL surgery. Knee Surg Sports Traumatol Arthrosc 31, 1690–1698 (2023). https://doi.org/10.1007/s00167-022-07000-8
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DOI: https://doi.org/10.1007/s00167-022-07000-8