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Long-Term Follow-Up of LARS Ligament Treatment for Unstable Knee ACL Deficiency

This study examines the efficacy of LARS ligament treatment for unstable knee ACL deficiency and reports long-term functional outcomes. The results show no significant change in Lachman Noulis test, Pivot Shift test, and IKDC score over time, and improvements in knee pain, stiffness, stability, and activity level.

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Long-Term Follow-Up of LARS Ligament Treatment for Unstable Knee ACL Deficiency

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  1. Treatment of unstable knee ACL deficiency using the new generation LARS artificial ligamentLong-term follow-up of 162 operated knees in 155 patients Maj. Gen. Greg. PapadopoulosMD, Lt. Col Sp. Darmanis MD, D. KiatosPHT Orthopedicand Trauma Department Athens Military Hospital and Iaso General Hospital Athens, GreeceIasimoRehabilitation Centre, Athens, Greece

  2. Background • Traditional ACL-R has achieved good-to-excellent results in only 60% of patientsFu et al 2008 • 63% of ACLRs returned to their pre-injury activity level after 12 months • 44% returned to competitive sport at 36.7 months post-opArdern & Feller et al 2011 • Mid (≤ 96months) to long -term (15 yrs) failure rates quoted at between 1 - 16% for autograftsPinczewski 2011, Magnusson 2011, Li 2010

  3. Background • Over 78% patients experience donor site pain with HT at up to 3 yrs post-op • Between 3-27% HT strength deficits compared with non-operated side Feller et al 2011 • Incomplete graft ligamentisation at up to 2 years after ACLR Janssen 2011, Claes 2011 • Autologous grafts approached only 50–60% of the intact ACL failure strength at up to 12 mnths in sheep studiesScheffler 2005, 2008

  4. Why LARS? • Avoids donor site morbidity or any other iatrogenic injury • Provides the possibility of natural ligament healing and early proprioception Murray 2011, Ahn 2011 • Permits early rehabilitation leading to a faster return to work and sport What is LARS? • Soft tissue internal fixator – scaffold type • PET (polyethylene terephthalate) with unique, pre-twisted ‘free fibre’ design • Human ACL: 1730 Nt • LARS AC-100: 4700 Nt • AC-120: 5000 Nt

  5. Study objectives & design • Objective • To report long-term functional follow-up of LARS ligaments in patients withan unstable knee and ACL deficiency • Study design • Monocenter prospective case-series • Independant, blinded data analysis by AO foundation • Follow-up examinations at upto 14 yrs (Average follow up 11 yrs) • Lachman - Noulistest • Pivot shifttest • IKDC subjective

  6. Patients • Eligibilitycriteria • Patient withmatureskeleton • Unstable knee with ACL deficiency • Treated with LARS by same surgeon (Dr Papadopoulos) • Standardized rehabilitation program (same Center) • Consented to long term follow up • Exclusion: complicated ligament injuries, dislocation or fractures, non-compliant patients • 8-year enrollmentperiod: Jan 1996 toDec 2003 • 155 patients (162 knees) • Male:female = 123:32 • Meanage = 38 years(range 15-68) • Side = 76 R, 72 L, 7 R+L

  7. Injurycharacteristics ACL stump classification

  8. Status ofkneelesions Associated meniscus and ligamentous lesions Chondral lesions

  9. Operation technique Notchplasty = 18% Recommended LARS technique followed Preservation of stump where possible No tension philosophy

  10. Rehabilitation program No brace post-operative (OP) Immediate active quadriceps exercises Immediate full weight bearing CPM started on 2nd–3rd post-OP day Normal walking 1.5-2.5 weeks post-OP Joggingprogressive training from 4-6 weeks post-OP Return to vigorous activitiessports practiced 8-12 weeks post-OP

  11. Results: Lachman-Noulis No change in Lachman- Noulis test results over time, with up to 14 years FU Each of the 162 knees were evaluated twice 2 years apart

  12. Results: Pivot Shift No change in Pivot Shift test results over time, with up to 14 years FU Each of the 162 knees were evaluated twice 2 years apart

  13. Results: IKDC Nooverallsignificantchange in IKDC score over time, withupto 14 years FU Eachofthe 162 kneeswereevaluatedtwice 2 years apart (mixedmodelwithrepeatedmeasure)

  14. Results: IKDC adjusted for age <=30 >30-40 >40 • There is a significant age effect : • Patients in the older group have lower mean IKDC than younger patients by -2.5 points • There is some time-related decrease in IKDC, however the change is not significant

  15. Results*: Knee pain during daily activity *at final follow up time point 5 - I have no pain in my knee. 4 - I have some pain in my knee but this does not affect my daily activities. 3 - The pain affects my daily activities a little. 2 - The pain affects my daily activities moderately. 1 - The pain affects my daily activities a lot. 0 - The pain in my knee is severe. I can’t do my daily activities.

  16. Results*: Knee stiffness during daily activity 5 - I have no stiffness in my knee. 4 - I have some stiffness in my knee but this does not affect my daily activities. 3 - The stiffness in my knee affects my daily activities a little. 2 - The stiffness in my knee affects my daily activities moderately. 1 - The stiffness in my knee affects my daily activities a lot. 0 - The stiffness in my knee does not allow me to do my daily activities. *at final follow up time point

  17. Results*: Knee stabilityNoyes Personal Questionaire 20 - I have no giving way sign. 16 - I feel my knee unstable when I participate in contact sports or do heavy work. 12 - I feel my knee unstable when I go jogging, which restricts my sports activities or heavy work. 8 - I feel my knee unstable and I cannot participate in sports. - I often have giving way sign even when I walk. 0 - I have a big problem of stability when I must turn or suddenly change direction. *at final follow up time point

  18. Results*: Knee activity levelNoyes Personal Questionaire 20 - I have no restrictions. I have a normal knee. I can participate in contact sports. 16 - I participate in sports but with lower demands. 12 - I can do weekend sports with some symptoms. 8 - I cannot participate in sports at all. Only jogging with symptoms. 4 - I have problems in my daily activities. 0 - I have severe problems in my daily activities. *at final follow up time point

  19. Results*: EdemaNoyes Personal Questionaire *at final follow up time point 10 - I have no edema in my knee. 8 - My knee is edematous from time to time when I participate in competitive sports or do heavy work. 6 - My knee is edematous after sports or moderate work. 4 - The edema limits my sports activities more than 4 times a year. 2 - My knee is edematous after running and the edema disappears after relaxing. 0 - My knee is edematous even when I walk and this remains after relaxing

  20. Revisions • Overall failure rate: 5.5% (9 Knees) • 2 knees, 1.2% due to graft rupture (technical error) • 3 knees, 1.8% due to persisting joint instability following trauma (re-tightening ) • 4 knees, 2.5% due to new trauma to the knee • Revised to: • Autogenous (3) • LARS (2) • Stand by (1) • Mini revision (3) • Minor complications • Superficial infection in the tibial portal – 3 knees, 1.8% • Lack of extension – 2 knees, 1.2% • Staple removal – 2 knees, 1.2% • 0% synovitis

  21. Revisions • Analysis of a failure case • We found revision of a LARS to be a simple procedure • Remove all fixation • Apply a very strong clamp applying mild traction • If the ligament wont strip out, pass a blunt K wire into tunnel, drill over with 4.5mm drill at low speed

  22. Discussion In our centre, LARS ACL has demonstrated excellent patient outcomes at an average follow up of 11 yrs These failure rates are comparable to published HT and PT results at the same average follow up interval Pinczewski 2007 Wipfler 2011 Acute cases of ACL injury and those of chronic laxities with well-vascularised ACL-stump are the best indications to use the LARS ligament Weaknesses: No radiographic follow up, further objective/subjective testing could have been included in this study

  23. Conclusions LARS has not exhibited high rates of complications associated with previous synthetics LARS avoids donor site complications associated with autografts Does not “burn any bridges” for possible revision surgery Provides the possibility of natural ligament healing and early proprioception Murray 2011, Ahn 2011 Permits early rehabilitation leading to a faster return to work and sport

  24. Thank you for your attention

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