ACL TightRope® Implant

Scientific Update

The TightRope implant, which has been used in 2 million procedures globally,1 simplifies
ACL reconstruction and facilitates advanced techniques such as the GraftLink® technique.
This update summarizes the published biomechanical and clinical ACL studies for the ACL
TightRope implant.

In Vivo Citations: Clinical Outcomes

Kulshrestha V, Original study: early patient-reported functional outcome of all-inside ACL reconstruction
Sood M,
as compared to anteromedial portal technique. Eur J Orthop Surg Traumatol. 2021;10.1007/
Kumar S,
s00590-021-02912-6. doi:10.1007/s00590-021-02912-6
Kawale A
■ In
this randomized study, 80 young active males requiring ACL reconstruction surgery
were equally randomized to anteromedial portal technique and all-inside technique.
■ Themean improvement in Tegner score was significantly better as compared to the
anteromedial portal technique group.
■ All-inside
ACL reconstruction provides a better chance of return to preinjury level of activity
with accompanied patient satisfaction as compared to anteromedial portal technique.

Kamitani A, Adjustable-loop devices promote graft revascularization in the femoral tunnel after ACL
Hara K,
reconstruction: comparison with fixed-loop devices using magnetic resonance angiography.
Arai Y,
Orthop J Sports Med. 2021. doi:10.1177/2325967121992134
et al
■ In
this Level 3 cohort study, 42 patients underwent ACL reconstruction using quadrupled
semitendinosus autograft and inside-out tunnel preparation.
■ This
is the first study to compare graft revascularization in vivo between fixed-loop devices
(FLDs) (Smith & Nephew Endobutton™) and adjustable-loop devices (ALDs) (Arthrex
TightRope® implant TR) in vivo, focusing on the contact area between the graft and femoral
tunnel wall.
■ MRA imaging at three-months post-ACL reconstruction showed that blood flow reached
the superior end of the tendon graft in the femoral tunnel in more patients who underwent
ACL reconstruction with an ALD than with an FLD.
■ Findings suggest that the increased graft-to-bone contact area created by ALDs leads
to earlier revascularization (0 to 3 months) in the superior end of the socket compared to
FLDs, which leave a gap between the graft tip and the superior end of the socket.
■ Thisstudy’s conclusion supports the long-discussed value of TightRope implants to
retension and fully seat grafts to achieve the “potted plant” effect.

Uribe-Echevarria B, Anterior cruciate ligament reconstruction: a comparative clinical study between adjustable
Magnuson JA,
and fixed length suspension devices. Iowa Orthop J. 2020;40(1):121-127.
Amendola A,
■ The purpose of this Level IV evidence study is to prospectively measure graft elongation in
Bollier MJ,
Wolf BR, vivo along with patient-reported outcomes.
Hettrich CM
■ Thirty-seven
skeletally mature patients diagnosed with anterior cruciate insufficiency who
underwent ACL reconstruction using autogenous hamstring graft were included in this study.
■ Theadjustable-length cortical suspension device did not demonstrate increased laxity as
compared to fixed-length devices. There was no difference in patient-reported outcomes
between the groups.
Smith PA, All-inside quadrupled semitendinosus autograft shows stability equivalent to patellar tendon
Cook CS,
autograft anterior cruciate ligament reconstruction: randomized controlled trial in athletes 24
Bley JA
years or younger. Arthroscopy. 2020;36(6):1629-1646. doi:10.1016/j.arthro.2020.01.048
■ All-inside
quadrupled semitendinosus grafts are suitable in high-risk patients as
BTB alternative.
■ This
randomized controlled trial compared clinical outcomes of knee ACL autograft
reconstruction using all-inside quadrupled semitendinosus vs bone-patellar tendon-bone
(BPTB) in high-risk young athletes.
■ ACLreconstruction with an all-inside quadrupled semitendinosus autograft construct is
equivalent to patellar BPTB autograft.

Onggo JR, Fixed- versus adjustable-loop devices for femoral fixation in anterior cruciate ligament
Nambiar M,
reconstruction: a systematic review. Arthroscopy. 2019;35(8):2484-2498. doi:10.1016/j.
Pai V
arthro.2019.02.029
■ Amultidatabase search was performed in July 2018 according to PRISMA guidelines.
Articles directly comparing FLDs and ALDs were included.
■ Thirteen biomechanical, two prospective, and six retrospective studies were included.
Clinical studies showed no statistically significant differences in clinical, functional,
radiologic, and complication outcomes between the two groups.
■ FLDsand ALDs produced similar clinical outcome scores and graft re-rupture rates.
“Biomechanical outcomes were improved with retensioning of ALDs after tibial fixation, as
per manufacturer recommendations.”

Ranjan R, In vivo comparison of a fixed loop (EndoButton CL) with an adjustable loop (TightRope RT)
Gaba S,
device for femoral fixation of the graft in ACL reconstruction: a prospective randomized
Goel L,
study and a literature review. J Orthop Surg (Hong Kong). 2018;26(3):2309499018799787.
et al
doi:10.1177/2309499018799787
■ IKDCand Lysholm scores, knee stability by AP laxity, and SSD using KT-1000 were used to
determine functional outcomes between TightRope® implant and Endobutton during ACL
reconstruction.
■ Knee stability and SSD were statistically insignificant between the two groups at both
six months and two years. At final follow-up (two years), the IKDC and Lysholm results
between TightRope implant and Endobutton were similar; however, at six-months post-op,
the Endobutton appeared to be better.
■ ACLreconstruction with either TightRope implant or Endobutton for femoral fixation “gives
substantially equivalent functional results and knee stability at mid-term follow-up.”
Burton DA, Primary anterior cruciate ligament repair using suture tape augmentation: a case series of
Schaefer EJ,
29 patients with minimum 2-year follow-up. Arthroscopy. 2021;37(4):1235-1241. doi:10.1016/j.
Shu HT,
arthro.2020.11.034
Bodendorfer BM,
Argintar EH ■ Toevaluate clinical outcomes and patient-reported outcomes of patients who underwent
primary ACL repair using suture tape augmentation.
■ In
this Level IV prospective case series, patients with a proximal tear of the ACL who
underwent primary ACL repair with a minimum two-year follow-up were included.
■ Primarysurgical repair of proximal ACL tears using suture tape augmentation results in a
low rate of revision surgery, which 2 of 29 patients required.

Parkes CW, Hamstring autograft anterior cruciate ligament reconstruction using an all-inside technique
Leland DP,
with and without independent suture tape reinforcement. Arthroscopy. 2021;37(2):609-616.
Levy BA,
doi:10.1016/j.arthro.2020.09.002
et al
■ This
is a 1:2 matched-cohort comparison of patients who underwent hamstring autograft
ACLR with and without independent suture tape reinforcement.
■ This is a Level III, retrospective comparative study.
■ ACL reconstruction with hamstring autografts and independent suture tape reinforcement
result in low complication, low graft failure, and low reoperation rates.

Yasen SK, Clinical outcomes of anatomic, all-inside, anterior cruciate ligament (ACL) reconstruction.
Borton ZM,
Knee. 2017;24(1):55-62. doi:10.1016/j.knee.2016.09.007
Eyre-Brook AI,
■ Two-year outcomes of 108 patients treated with ACL reconstruction using the GraftLink®
et al
technique (FlipCutter® reamer, ACL TightRope® implant, and quadrupled semitendinosus
autograft) are reported.
■ TheGraftLink technique demonstrates good short- to medium-term subjective and
objective outcomes with low complication and failure rates.

Schurz M, Clinical and functional outcome of all-inside anterior cruciate ligament reconstruction
Tiefenboeck TM,
at a minimum of 2 years’ follow-up. Arthroscopy. 2016;32(2):332-337. doi:10.1016/j.
Winnisch M,
arthro.2015.08.014
et al
■ All-inside
ACL reconstruction using the GraftLink technique leads to improved functional
outcomes in active patients at a minimum follow-up of two years.
■ Nodifference was noted in stability between the ACL-reconstructed and the contralateral
normal knee at two years.

Boyle MJ, Does adjustable-loop femoral cortical suspension loosen after anterior cruciate ligament
Vovos TJ,
reconstruction? A retrospective comparative study. Knee. 2015;22(4): 304-308. doi:10.1016/j.
Walker CG,
knee.2015.04.016
Stabile KJ,
Roth JM, ■ Adjustable-loop suspension does not clinically loosen after ACL reconstruction.
Garrett WE, Jr
■ Therewas no significant difference in postoperative knee stability or graft failure
rate between adjustable-loop and fixed-loop femoral cortical suspension in patients
undergoing primary ACL reconstruction.
Benea H, Pain evaluation after all-inside anterior cruciate ligament reconstruction and short term
d’Astorg H,
functional results of a prospective randomized study. Knee. 2014;21(1):102-106. doi:10.1016/j.
Klouche S,
knee.2013.09.006
Bauer T,
Tomoaia G, ■ Theresults show that postoperative pain, knee stability, ranges of motion, and transplant
Hardy P positioning were slightly better with the all-inside technique.
■ Theall-inside technique can be considered a valid, reliable procedure with very good
results for pain, stability, and knee function. It is a promising option for minimally invasive
ACL reconstruction.

Blackman AJ, All-inside anterior cruciate ligament reconstruction. J Knee Surg. 2014;27(5):347-352.
Stuart MJ
doi:10.1055/s-0034-1381960
■ Reports suggest similar results in the early postoperative period when compared with
traditional techniques.
■ All-inside
techniques offer the advantages of improved cosmesis, less postoperative pain,
decreased bone removal, and gracilis preservation.

In Vitro Citations: Biomechanical Validation

Uchida R, Excellent bone plug-socket integration at 8 weeks after anterior cruciate ligament
Nakamura N,
reconstruction using an adjustable-length loop cortical fixation device. J ISAKOS. 2019;4(1):9-
Suzuki T,
14. doi:10.1136/jisakow-2018-000244
et al
■ This
clinical study evaluated bone plug-socket integration in ACL reconstructions using the
BTB TightRope® implant.
■ Twentypatients with BTB TightRope implants underwent CT at four and eight weeks
postoperatively for assessment of the union between the graft and socket wall. Patients
were also evaluated at two years using IKDC and KT-2000 knee stability measurement.
■ Excellentbone integration was observed at eight weeks. All knees were rated normal
or nearly normal according to IKDC with a mean side-to-side difference of 0.2 mm.
Adjustable-length loop cortical fixation devices could be safely applied for anatomic
rectangular tunnel ACL reconstruction.

Monaco E, Intraoperative workflow for all-inside anterior cruciate ligament reconstruction: an in vitro
Bachmaier S,
biomechanical evaluation of preconditioning and knot tying. Arthroscopy. 2018;34(2):538-
Fabbri M,
545. doi:10.1016/j.arthro.2017.08.283
Lanzetti RM,
Wijdicks CA, ■ Fourall-inside ACL reconstruction groups were evaluated. Groups included one or both
Ferretti A sides knotted and with and without intraoperative preconditioning.
■ Initial
graft tension is increased with intraoperative preconditioning in single-side knotted
and both-side knotted groups versus without preconditioning. Furthermore, dynamic
elongation is reduced for single-side knotted and both-side knotted constructs.
■ “All-inside
ACL reconstruction with preconditioning according to intraoperative workflow
leads to a statistically significant improved mechanical behavior and may allow for
optimizing initial graft tension and elongation for all-inside ACL reconstruction to reduce
knee laxity.”
Noonan BC, Intraoperative preconditioning of fixed and adjustable loop suspensory anterior cruciate
Bachmaier S,
ligament reconstruction with tibial screw fixation – an in vitro biomechanical evaluation using
Wijdicks CA,
a porcine model. Arthroscopy. 2018;34(9):2668-2674. doi:10.1016/j.arthro.2018.04.014
Bedi A
■ Biomechanical evaluation of three ACL reconstruction techniques using suspensory
femoral fixation and interference screw tibial fixation. The groups were: group 1: ALD and
screw; group 2: preconditioned ALD and screw; and group 3: closed loop and screw.
■ Surgical placement of an interference screw imparted a time-zero laxity of 0.53 mm and
loss of tension (62%).
■ The operating characteristics of the TightRope® implant allow for restoration of screw-
induced graft slackening and optimizing tension. This was not possible with an FLD
(Endobutton). Total elongation varied across groups, with group 2 (preconditioned ALD)
showing the least elongation (group 1: 2.22 ± 0.52; group 2: 0.65 ± 0.29; and group 3: 1.79
± 0.28).
■ ACL reconstruction with femoral TightRope implant fixation and intraoperative
preconditioning allows for the restoration of time-zero screw-imparted slack and leads to
significantly reduced cyclic elongation in accordance with native ACL function.

Smith PA, Adjustable- versus fixed-loop devices for femoral fixation in ACL reconstruction:
Piepenbrink M,
an in vitro full-construct biomechanical study of surgical technique-based tibial
Smith SK,
fixation and graft preparation. Orthop J Sports Med. 2018;6(4):2325967118768743.
Bachmaier S,
Bedi A, doi:10.1177/2325967118768743
Wijdicks CA ■ This
was the first study to test biomechanical strength of the entire graft construct with an
expanded cycling protocol.
■ Thelargest pull-to-failure force was observed for the TightRope implant/GraftLink®
technique construct, which was statistically significantly different than all other devices.
■ The ACL TightRope implant is the only device that was effectively retensioned.
■ Elongation with the ACL TightRope implant construct was comparable to FLDs.
■ TheGraftMax™ button (ConMed) exceeded maximum elongation limits for ACL
reconstruction.
■ TheUltrabutton™ adjustable fixation device (Smith & Nephew) lost the greatest amount of
force during cycling.

Kusano M, Loop length change of an adjustable-length femoral cortical suspension device in anatomic
Kazui A,
rectangular tunnel anterior cruciate ligament reconstruction with a bone-patellar tendon-
Uchida R,
bone graft and associated clinical outcomes. Arthroscopy. 2018;34(11):3063-3070. doi.
Mae T,
Tsuda T, org/10.1016/j.arthro.2018.06.034
Toritsuka Y ■ This
clinical study evaluated ACL reconstruction with a BTB graft fixed using a BTB
TightRope implant.
■ The loop length of the BTB TightRope implant was measured by CT at 1 and 12 weeks after
the surgery. Subjective and objective outcomes scores were also assessed at 2 years
postoperatively.
■ The loop length change of the BTB TightRope implant was negligible at 12 weeks.
At 2-years postoperatively, 98% of patients were graded as normal or nearly normal
according to IKDC with side-to-side difference of 0.2 mm.
Chang MJ, A comparative biomechanical study of femoral cortical suspension devices for soft-tissue
Bae TS,
anterior cruciate ligament reconstruction: adjustable-length loop versus fixed-length loop.
Moon YW,
Arthroscopy. 2018;34(2):566-572. doi:10.1016/j.arthro.2017.08.294
Ahn JH,
Wang JH ■ AnACL TightRope® implant was tested against Endobutton (FLD) in a device-only model as
well as in a biomechanical model.
■ Therewere no significant differences in terms of total displacement, temporal pattern of
displacement, or ultimate failure load between the devices.

Mickelson DT, Adjustable-loop femoral cortical suspensory fixation for patellar tendon anterior cruciate
Lefebvre T,
ligament reconstruction: a time zero biomechanical comparison with interference screw
Gall K,
fixation. Am J Sports Med. 2018;46(8):1857-1862. doi:10.1177/0363546518771365
Riboh JC
■ This
biomechanical study compared BTB TightRope implants and metallic interference
screws in an ACL reconstruction.
■ Human BTB grafts were fixated into porcine femurs with a BTB TightRope implant or
metallic interference screw and biomechanically tested.
■ Authorscompared time zero biomechanical properties between metallic interference
screws and ALCFD for femoral fixation of bone-tendon-bone grafts in ACL reconstruction.
■ TheALCFD and interference screws were divided into two groups (eight samples each) and
human bone-tendon-bone allografts were fixated in porcine distal femurs. The constructs
were preconditioned and subjected to cyclic loading before being pulled to failure.
■ The loads to failure (mean ± SD, 700 ± 256 N compared to 688 ± 215 N, P = .92) and linear
stiffness (219 ± 48 N/mm compared to 218 ± 49 N/mm, P = .97) were not significantly
different between the ALCFD and interference screw groups, respectively. The authors
concluded that ALDs are acceptable alternatives to an interference screw for femoral
fixation during ACL reconstruction with BTB grafts.

Nye DD, Biomechanical comparison of fixed-loop and adjustable-loop cortical suspensory devices for
Mitchell WR,
metaphyseal femoral-sided soft tissue graft fixation in anatomic anterior cruciate ligament
Liu W,
reconstruction using a porcine model. Arthroscopy. 2017;33(6):1225-1232.e1. doi:10.1016/j.
Ostrander RV
arthro.2016.12.014
■ Fixed-and adjustable-loop buttons were tested on metaphyseal bone. This type of testing
is much more relevant than pure mechanical testing which doesn’t take in vivo conditions
(bone, tissue, button position, etc) into consideration.
■ The
ACL TightRope implant was biomechanically equivalent to fixed-loop button fixation,
whereas the Ziploop™ (Zimmer Biomet) showed statistically significantly lower stiffness and
more displacement during cycling.
Noonan BC, Biomechanical evaluation of an adjustable loop suspensory anterior cruciate ligament
Dines JS,
reconstruction fixation device: the value of retensioning and knot tying. Arthroscopy.
Allen AA,
2016;32(10):2050-2059. doi:10.1016/j.arthro.2016.02.010
Altchek DW,
Bedi A ■ ACL TightRope® RT implants were tested against the Endobutton device using an
expanded cycling protocol similar to previous studies (Barrow et al, Am J Sports Med.
2014;42(2):343-349; Johnson et al, Am J Sports Med. 2015;43(1):154-160). ACL TightRope
implants were tested without retensioning, with retensioning, with knotted shortening
strands, and with retensioning plus knotted shortening strands.
■ ACL TightRope implants without retensioning were within 0.4 mm of Endobutton devices.
This difference was deemed not clinically significant by the authors (P = .101).
■ Retensioned and knotted ACL TightRope implants displaced less than all other groups,
including Endobutton devices. Ultimate loads were similar.
■ Retensioned and knotted ACL TightRope implants showed the lowest cyclic displacement.
However, all displacements were within a fraction of a millimeter, so there is likely no
clinical importance.

Johnson JS, A biomechanical comparison of femoral cortical suspension devices for soft tissue anterior
Smith SD,
cruciate ligament reconstruction under high loads. Am J Sports Med. 2015;43(1):154-160.
LaPrade CM,
doi:10.1177/0363546514553779
Turnbull TL,
LaPrade RF, ■ The TightRope implant with retensioning increases the ultimate strength (1020 N), reduces
Wijdicks CA the cyclic displacement to 1.81 ± 0.51 mm, and is placed in the sub-2 mm category with FLDs.

Smith PA, Tibial fixation properties of a continuous-loop ACL hamstring graft construct with suspensory
DeBerardino TM
fixation in porcine bone. J Knee Surg. 2015;28(6):506-512. doi:10.1055/s-0034-1394167
■ All-inside
GraftLink® continuous-loop soft-tissue graft with TightRope suspensory fixation
provided adequate strength for tibial fixation in ACL reconstruction and is superior to
interference screw fixation.

Petre BM, Femoral cortical suspension devices for soft tissue anterior cruciate ligament
Smith SD,
reconstruction: a comparative biomechanical study. Am J Sports Med. 2013;41(2):416-422.
Jansson KS,
doi:10.1177/0363546512469875
et al
■ The TightRope implant has the necessary biomechanical properties with regard to ultimate
failure strength, displacement, and stiffness for initial fixation of soft-tissue grafts in the
femoral tunnel for ACL reconstruction.
■ Ultimate failure strength was greater than the previously reported strength needed for
activities of daily living and rehabilitation exercises.
■ The TightRope implant construct reapproximated the native stiffness of the ACL.
 (Misleading Literature) In Vitro Citations: Biomechanical Validation
Mayr R, Biomechanical comparison of 2 anterior cruciate ligament graft preparation techniques for
Heinrichs CH,
tibial fixation: adjustable-length loop cortical button or interference screw. Am J Sports Med.
Eichinger M,
2015;43(6):1380-1385. doi:10.1177/0363546515574062
Coppola C,
Schmoelz W, ■ Grafts only pretensioned to 11 lb (50 N) for 5 minutes. Arthrex GraftLink® technique
Attal R pretensions grafts to 20 lb (80 N) on the GraftPro® board. Once implanted, grafts can
be tensioned and retensioned after cycling, which would eliminate the first 2 stages of
displacement and bring the total GraftLink technique displacement to 3 mm.
■ Graftwas prepared insufficiently. Only three passes of FiberLoop® suture were used and
they were not retained for backup.

Barrow AE, Femoral suspension devices for anterior cruciate ligament reconstruction: do adjustable
Pilia M,
loops lengthen? Am J Sports Med. 2014;42(2):343-349. doi:10.1177/0363546513507769
Guda T,
Kadrmas WR,
■ See DeBerardino TM, Smith PA, Cook JL. Femoral suspension devices for anterior cruciate
Burns TC ligament reconstruction: letter to the editor. Am J Sports Med. 2014;42(2):NP15-6.
■ While the cause of the error is unknown, possible hypotheses are improper loading of the
device, improper manipulation of the device, and/or poor calibration of their testing machine.

Reference

1. Arthrex, Inc. Sales data on file (as of July 10, 2018). Naples, FL; 2018.

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