Long-term results of a randomized study on anterior cruciate ligament reconstruction with or without a synthetic degradable augmentation device to support the autograft
- 770 Downloads
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.
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.
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.
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.
KeywordsACL BPTB Artelon Ligament augmentation Patella tendon
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.
Conflict of interest
The first author owns shares in the sponsoring company and is since 2011 a board member.
- 4.Bird JH, Carmont MR, Dhillon M, Smith N, Brown C, Thompson P, Spalding T (2011) Validation of a new technique to determine midbundle femoral tunnel position in anterior cruciate ligament reconstruction using 3-dimensional computed tomography analysis. Arthroscopy 27:1259–1267PubMedCrossRefGoogle Scholar
- 11.European Medicines Agency (2011) Guideline on missing data in confirmatory clinical trials. EMA/CPMP/EWP/1776/99 Rev. 1. http://www.ema.europa.eu/ema/
- 12.Food and Drug Administration. Guidance document for the preparation of investigational device exemptions and premarket approval applications for intra-articular prosthetic knee ligament devices 1987, revised 1993. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081345.pdf
- 18.Lidén M, Sernert N, Rostgård-Christensen L, Kartus C, Ejerhed L (2008) Osteoarthritic changes after anterior cruciate ligament reconstruction using bone-patellar tendon-bone or hamstring tendon autografts: a retrospective, 7-year radiographic and clinical follow-up study. Arthroscopy 24:899–908PubMedCrossRefGoogle Scholar
- 20.Linko E, Harilainen A, Malmivaara A, Seitsalo S (2005) Surgical versus conservative interventions for anterior cruciate ligament ruptures in adults. Cochrane Database Syst Rev 18:CD001356Google Scholar
- 31.Peterson L, Brittberg M (1998) Articular cartilage classification. International Cartilage Repair Society: Newsletter, Issue Spring, pp 6–8Google Scholar
- 36.Rushton N, Dandy DJ, Naylor CPE (1983) The clinical, arthroscopic and histological findings after replacement of the anterior cruciate ligament with carbon-fibre. J Bone Joint Surg 65:308–309Google Scholar