Abstract
Purpose
The aim was to compare the outcome of anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft, with and without a poly(urethane urea) augmentation device.
Methods
Patients were randomized to BPTB reconstruction with a synthetic degradable augmentation device (n = 96) or without augmentation (n = 105). Follow-ups were made during 4 years after surgical treatment with the KT1000™ arthrometer for objective evaluation of sagittal stability. The Tegner scoring system for assessment of physical activity level and the Knee injury Osteoarthritis Outcome Score (KOOS) for assessment of knee-specific health were evaluated after 4 and 12 years.
Results
KT1000™ tests showed a significant decrease in mean manual maximum side-to-side difference after 4 years in both patients with and those without augmentation, without any statistical difference between the groups (n.s.). Pre-injury, 76 and 80 % of the patients, respectively, reported Tegner level 7–10. Pre-surgery, the corresponding figures were 6 and 5 %, and at 4 years, 33 and 30 %. Twelve years after ACL reconstruction, both groups had significantly higher KOOS scores in function in sports and recreational activities (p < 0.001) and knee-related quality of life (p < 0.001) compared to before surgical treatment. In 10 patients, the augmentation device was removed, in six of these because of insufficient screw fixation to femur and in four due to swelling/hydrops.
Conclusion
This study showed no significant difference in clinical outcome with use of an additional synthetic augmentation device in a single-bundle BPTB ACL reconstruction compared with non-augmentation, in short, intermediate, or long-term perspective.
Level of evidence
Therapeutic study, Level I.
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Acknowledgments
The study was sponsored by Artimplant AB, Gothenburg, Sweden. The authors gratefully acknowledge the physical therapist at each of the involved centres for professional work with the follow-ups.
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The first author owns shares in the sponsoring company and is since 2011 a board member.
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Peterson, L., Eklund, U., Engström, B. et al. Long-term results of a randomized study on anterior cruciate ligament reconstruction with or without a synthetic degradable augmentation device to support the autograft. Knee Surg Sports Traumatol Arthrosc 22, 2109–2120 (2014). https://doi.org/10.1007/s00167-013-2636-3
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DOI: https://doi.org/10.1007/s00167-013-2636-3