To the Editor:
With great interest, we recently read the article entitled “Synthetic Devices for Reconstructive Surgery of the Cruciate Ligaments: A Systematic Review” published in the May 2015 issue of Arthroscopy.
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Thank you for acknowledging our skepticism about the resurgent use of synthetic grafts in your editorial commentary.2
At first blush, this systematic review of synthetic implants, particularly the Ligament Augmentation and Reconstruction System (LARS) device (Surgical Implants and Devices, Arc-sur-Tille, France), shows quite good results, almost too good to be true. However, this highlights one of the inherent problems with systematic reviews. In other words, the science and methodology are sound and well intentioned, but they tend to encompass investigations with bad science, significant confounding, or notable conflicts of interest. Many of the included papers that are reviewed reveal subtle sources of bias: selection bias in sedentary patient recruitment, reporting bias with a lack of patient-reported functional activity levels, and non-responder bias that fails to account for clinical failures on subsequent follow-up. Where is the common sense?Anyone who has worked with this graft option is well aware of its high failure rate in active cohorts. The published literature is also replete with reports of its pitfalls, including issues related to attritional wear particles, pseudoseptic synovitic reaction, significant stress shielding, and poor biologic integration.
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Despite its initial development in France, the French medical society banned its use nearly 15 years ago. Prior to its latest resurgence in Asia and Australia, many vocal critics attempted to prohibit use of the LARS graft, in large part due to some high-profile failures among professional rugby athletes and inconsistency in clinical results.4
Currently, the Food and Drug Administration only provides for conditional use of graft augmentation devices in certain salvage situations in the United States. Where is the common sense?Consensus statement by orthopaedic surgeons from the North Sydney Orthopaedic and Sports Medicine Centre. LARS ligament and ACL reconstruction. Available at http://www.nsosmc.com.au/information.html. Accessed July 1, 2015.
Current synthetic grafts are marketed for patients desiring an early aggressive rehabilitation and rapid return to athletic function. However, among active, pivoting athletes, synthetic grafts have classically failed by abrasion about the femoral tunnel. In our anecdotal experience, the senior author had a 40% failure rate at 2 years for posterior cruciate ligament reconstruction using the LARS device. Subsequent revisions were complicated and required extensive debridement of all the synthetic particulate debris and grafting of sizable bony defects. Is this 2-stage procedure good for the patient? Despite redesigning by the manufacturer to limit complications associated with its predecessors, the long-term track record of the third-generation LARS is sparse and the methodologic quality of existing studies is fairly poor. Many authors also continue to recommend against routine, first-line use of the LARS graft
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or consider its use in only older, lower-demand patients.6
When evaluating synthetic grafts and their potential utility in knee reconstruction, we need to be careful about the messages we promote to patients, surgeons, and health care policymakers and avoid reproducing the errors of history. We are, however, excited to see a renewed focus and further innovation in primary anterior cruciate ligament repair, as there have been numerous improvements over the Marshall technique dating back to the 1980s. The use of a small-diameter, synthetic “internal brace” can protect the repair construct during the healing phase,
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while the addition of biologic healing, whether “healing response” through stimulation of the notch wall- Mackay G.M.
- Blyth M.J.
- Anthony I.
- Hopper G.P.
- Ribbans W.J.
A review of ligament augmentation with the InternalBrace: The surgical principle is described for the lateral ankle ligament and ACL repair in particular, and a comprehensive review of other surgical applications and techniques is presented.
Surg Technol Int. 2015; 26: 239-255
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or the incorporation of a super clot described by Proffen et al.,9
may facilitate greater tissue remodeling. For acute, proximal anterior cruciate ligament tears, primary repair in selected high-functioning athletes may quickly emerge as a successful operation for earlier return to previous level of activity. Now that is common sense!References
- Synthetic devices for reconstructive surgery of the cruciate ligaments: A systematic review.Arthroscopy. 2015; 31: 957-968
- Editorial commentary: Synthetic ACL grafts are more important than clinical nonbelievers may realize.Arthroscopy. 2015; 31: 969-970
- Disabling synovitis associated with LARS artificial ligament use in anterior cruciate ligament reconstruction: A case report.Am J Sports Med. 2012; 40: 1167-1171
Consensus statement by orthopaedic surgeons from the North Sydney Orthopaedic and Sports Medicine Centre. LARS ligament and ACL reconstruction. Available at http://www.nsosmc.com.au/information.html. Accessed July 1, 2015.
Tiefenboeck TM, Thurmaier E, Tiefenboeck MM, et al. Clinical and functional outcome after anterior cruciate ligament reconstruction using the LARS system at a minimum follow-up of 10 years. Knee in press, available online 26 June, 2015. doi:10.1016/j.knee.2015.06.003.
- Anterior cruciate ligament reconstruction with LARS artificial ligament results at a mean follow-up of eight years.Int Orthop. 2013; 37: 1567-1574
- A review of ligament augmentation with the InternalBrace: The surgical principle is described for the lateral ankle ligament and ACL repair in particular, and a comprehensive review of other surgical applications and techniques is presented.Surg Technol Int. 2015; 26: 239-255
- Outcomes following healing response in older, active patients: A primary anterior cruciate ligament repair technique.J Knee Surg. 2012; 25: 255-260
- Bio-enhanced repair of the anterior cruciate ligament.Arthroscopy. 2015; 31: 990-997
Article info
Footnotes
Note: The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or reflecting the views of the Department of Defense or the US government. The authors are employees of the US government. The authors report the following potential conflict of interest or source of funding: D.H.J. receives support from Arthrex, Wolter Kluwer Health, and Lippincott Williams & Wilkins.
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© 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
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- Synthetic Devices for Reconstructive Surgery of the Cruciate Ligaments: A Systematic ReviewArthroscopyVol. 31Issue 5
- Authors' ReplyArthroscopyVol. 31Issue 10
- PreviewWe greatly appreciate the comments made by Drs. Waterman and Johnson regarding our publication in the ISAKOS Biologics Series Part II supplement of the May 2015 issue of Arthroscopy, entitled “Synthetic Devices for Reconstructive Surgery of the Cruciate Ligaments: A Systematic Review,”1 along with the editorial comment made by Dr. Lubowitz in the same supplement.2 The Ligament Augmentation and Reconstruction System (LARS) device, in particular, draws the most attention.
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- Synthetic GraftsArthroscopyVol. 32Issue 4
- PreviewThe LARS Company (Arc-sur-Tille, France) would like to exercise its right to reply to a letter to the editor entitled “Synthetic Grafts—Where Is the Common Sense?” by Waterman and Johnson published in Arthroscopy.1 Their letter refers to an article entitled “Synthetic Devices for Reconstructive Surgery of the Cruciate Ligaments: A Systematic Review,”2 which was based on correct information and strong scientific data and published in the May 2015 issue of Arthroscopy.
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