Skip to main content
Log in

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
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Similar content being viewed by others

References

  1. Asahina S, Yamamoto H, Muneta T, Ishibashi T, Furuya K (1995) Evaluation of anterior cruciate reconstruction reinforced by the Kennedy ligament augmentation device. An arthroscopic and histological study. Int Orthop 19:229–233

    Article  CAS  PubMed  Google Scholar 

  2. Bach BR Jr, Warren RF, Flynn WM, Kroll M, Wickiewiecz TL (1990) Arthrometric evaluation of knees that have a torn anterior cruciate ligament. J Bone Joint Surg Am 72:1299–1306

    PubMed  Google Scholar 

  3. Barrett GR, Field LD (1993) Comparison of patella tendon versus patella tendon/Kennedy ligament augmentation device for anterior cruciate ligament reconstruction: study of results, morbidity, and complications. Arthroscopy 9:624–632

    Article  CAS  PubMed  Google Scholar 

  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 27:1259–1267

    Article  PubMed  Google Scholar 

  5. Church S, Keating JF (2005) Reconstruction of the anterior cruciate ligament. Timing of surgery and the incidence of meniscal tears and degenerative change. J Bone Joint Surg Br 87:1639–1642

    Article  CAS  PubMed  Google Scholar 

  6. Clancy WG, Narechania RG, Rosenberg TD, Gmeiner JG, Wisnefske DD, Lange TA (1981) Anterior and posterior cruciate ligament reconstruction in Rhesus monkeys. J Bone Joint Surg Am 63:1270–1284

    PubMed  Google Scholar 

  7. Daniel DM, Stone ML, Sachs R, Malcom L (1985) Instrumented measurement of anterior knee laxity in patients with acute anterior cruciate ligament disruption. Am J Sports Med 13:401–407

    Article  CAS  PubMed  Google Scholar 

  8. Drogset JO, Grøntvedt T (2002) Anterior cruciate ligament reconstruction with and without a ligament augmentation device: results at 8-year follow-up. Am J Sports Med 30:851–856

    PubMed  Google Scholar 

  9. Dunn WR, Lyman S, Lincoln AE, Amoroso PJ, Wickiewicz T, Marx RG (2004) The effect of anterior cruciate ligament reconstruction on the risk of knee reinjury. Am J Sports Med 32:1906–1914

    Article  PubMed  Google Scholar 

  10. Englund M, Roos EM, Lohmander LS (2003) Impact of type of meniscal tear on radiographic and symptomatic knee osteoarthritis. A sixteen-year followup of meniscectomy with matched controls. Arthr Rheum 48:2178–2187

    Article  CAS  Google 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

  13. Gisselfält K, Edberg B, Flodin P (2002) Synthesis and properties of degradable poly(urethane urea)s to be used for ligament reconstructions. Biomacromolecules 3:951–958

    Article  PubMed  Google Scholar 

  14. Grøntvedt T, Engebretsen L, Bredland T (1996) Arthroscopic reconstruction of the anterior cruciate ligament using bone-patellar tendon-bone grafts with and without augmentation. J Bone Joint Surg Br 78:817–822

    PubMed  Google Scholar 

  15. Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC, Shelbourne KD (2001) Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med 29:600–613

    CAS  PubMed  Google Scholar 

  16. Kennedy JC, Roth JH, Mendenhall HV, Sanford JB (1980) Intraarticular replacement in the anterior cruciate ligament-deficient knee. Am J Sports Med 8:1–8

    Article  CAS  PubMed  Google Scholar 

  17. Legnani C, Ventura A, Terzaghi C, Borgo E, Albisetti W (2010) Anterior cruciate ligament reconstruction with synthetic grafts. A review of literature. Int Orthop 34:465–471

    Article  PubMed Central  PubMed  Google Scholar 

  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 24:899–908

    Article  PubMed  Google Scholar 

  19. Liljensten E, Gisselfält K, Edberg B, Bertilsson H, Flodin P, Nilsson A, Lindahl A, Peterson L (2002) Studies of polyurethane urea bands for ACL reconstruction. J Mater Sci Mater Med 13:351–359

    Article  CAS  PubMed  Google 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:CD001356

    Google Scholar 

  21. Liu Z-t, Zhang X-l, Jiang Y, Zeng B-F (2010) Four-strand hamstring tendon autograft versus LARS artificial ligament for anterior cruciate ligament reconstruction. Int Orthop 34:45–49

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  22. Lohmander LS, Englund PM, Dahl LL, Roos EM (2007) The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med 35:1756–1769

    Article  PubMed  Google Scholar 

  23. Maletius W, Gillquist J (1997) Long-term results of anterior cruciate ligament reconstruction with a Dacron prosthesis. The frequency of osteoarthritis after seven to eleven years. Am J Sports Med 25:288–293

    Article  CAS  PubMed  Google Scholar 

  24. Marberry TA (2013) A synthetic reinforcement patch in repair of challenging two-tendon rotator cuff tears. Should Elbow 5:24–29

    Article  Google Scholar 

  25. Meuffels DE, Favejee MM, Vissers MM, Heijboer MP, Reijman M, Verhaar JAN (2009) Ten year follow-up study comparing conservative versus operative treatment of anterior cruciate ligament ruptures. A matched-pair analysis of high level athletes. Br J Sports Med 43:347–351

    Article  CAS  PubMed  Google Scholar 

  26. Mody BS, Howard L, Harding ML, Parmar HV, Learmonth DJ (1993) The ABC carbon and polyester prosthetic ligament for ACL-deficient knees. Early results in 31 cases. J Bone Joint Surg Br 75:818–821

    CAS  PubMed  Google Scholar 

  27. Mott HW (1983) Semitendinosus anatomic reconstruction for cruciate ligament insufficiency. Clin Orthop Relat Res 172:90–92

    PubMed  Google Scholar 

  28. Nau T, Lavoi P, Duval N (2002) A new generation of artificial ligaments in reconstruction of the anterior cruciate ligament. Two-year follow-up of a randomised trial. J Bone Joint Surg Br 84:356–360

    Article  CAS  PubMed  Google Scholar 

  29. Nelson F, Billinghurst RC, Pidoux I et al (2006) Early post-traumatic osteoarthritis-like changes in human articular cartilage following rupture of the anterior cruciate ligament. Osteoarthr Cartil 14:114–119

    Article  CAS  PubMed  Google Scholar 

  30. Newman SDS, Atkinson HDE, Willis-Owen CA (2013) Anterior cruciate ligament reconstruction with the ligament augmentation and reconstruction system: a systematic review. Int Orthop (SICOT) 37:321–326

    Article  Google Scholar 

  31. Peterson L, Brittberg M (1998) Articular cartilage classification. International Cartilage Repair Society: Newsletter, Issue Spring, pp 6–8

  32. Rading J, Peterson L (1995) Clinical experience with the Leeds-Keio artificial ligament in anterior cruciate ligament reconstruction. A prospective two-year follow-up study. Am J Sports Med 23:316–319

    Article  CAS  PubMed  Google Scholar 

  33. Ristanis S, Stergiou N, Patras K, Tsepis E, Moraiti C, Georgoulis AD (2006) Follow-up evaluation 2 years after ACL reconstruction with bone-patellar tendon-bone graft shows that excessive tibial rotation persists. Clin J Sports Med 16:111–116

    Article  Google Scholar 

  34. Roolker W, Patt TW, van Dijk CN, Vegter M, Marti RK (2000) The Gore-Tex prosthetic ligament as a salvage procedure in deficient knees. Knee Surg Sports Traumatol Arthrosc 8:20–25

    Article  CAS  PubMed  Google Scholar 

  35. Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD (1998) Knee injury and Osteoarthritis Outcome Score (KOOS)—development of a self-administered outcome measure. J Orthop Sports Phys Ther 28:88–96

    Article  CAS  PubMed  Google 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 65:308–309

    CAS  Google Scholar 

  37. Schreiber VM, van Eck CF, Fu FH (2010) Anatomic double-bundle ACL reconstruction. Sports Med Arthrosc 18:27–32

    Article  PubMed  Google Scholar 

  38. Sernert N, Kartus J, Köhler K, Ejerhed L, Karlsson J (2001) Evaluation of the reproducibility of the KT-1000 arthrometer. Scand J Med Sci Sports 11:120–125

    Article  CAS  PubMed  Google Scholar 

  39. Shelbourne KD, Gray T (2000) Results of anterior cruciate ligament reconstruction based on meniscus and articular cartilage status at the time of surgery. Five- to fifteen-year evaluations. Am J Sports Med 28:446–452

    CAS  PubMed  Google Scholar 

  40. Shelbourne KD, Gray T, Haro M (2009) Incidence of subsequent injury to either knee within 5 years after anterior cruciate ligament reconstruction with patellar tendon autograft. Am J Sports Med 37:246–251

    Article  PubMed  Google Scholar 

  41. Smith GD, Taylor J, Almqvist KF et al (2005) Arthroscopic assessment of cartilage repair: a validation study of 2 scoring systems. Arthroscopy 21:1462–1467

    Article  PubMed  Google Scholar 

  42. Tashman S, Kolowich P, Collon D, Anderson K, Anderst W (2007) Dynamic function of the ACL-reconstructed knee during running. Clin Orthop Relat Res 454:66–73

    Article  PubMed  Google Scholar 

  43. Tegner Y, Lysholm J (1985) Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res 198:43–49

    PubMed  Google Scholar 

  44. van der Hart CP, van den Bekerom MPJ, Patt TW (2008) The occurrence of osteoarthritis at a minimum of ten years after reconstruction of the anterior cruciate ligament. J Orthop Surg Res 3:24

    Article  PubMed Central  PubMed  Google Scholar 

  45. von Porat A, Roos EM, Roos H (2004) High prevalence of osteoarthritis 14 years after an anterior cruciate ligament tear in male soccer players: a study of radiographic and patient relevant outcomes. Ann Rheum Dis 63:269–273

    Article  Google Scholar 

  46. Wredmark T, Engström B (1993) Five-year results of anterior cruciate ligament reconstruction with the Stryker Dacron high-strength ligament. Knee Surg Sports Traumatol Arthrosc 1:71–75

    Article  CAS  PubMed  Google Scholar 

  47. Zaricznyj B (1987) Reconstruction of the anterior cruciate ligament of the knee using a doubled tendon graft. Clin Orthop Relat Res 220:162–175

    PubMed  Google Scholar 

Download references

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.

Conflict of interest

The first author owns shares in the sponsoring company and is since 2011 a board member.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Lars Peterson.

Rights and permissions

Reprints and permissions

About this article

Cite this article

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

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00167-013-2636-3

Keywords

Navigation