TRONDHEIM, Norway–Publication of a third study1-3 showing high long-term failure rates with the popular, all-inside, Biofix Meniscus Arrow™ meniscus repair system (Bionx Implants, Blue Bell, Penn, and Tampere, Finland) looks likely to speed orthopedists' shift toward newer, suture-based methods, and even back toward "gold standard" inside-out sutures, experts tell CIAOMed.
The latest report, from Jon Olav Drogset, MD, and colleagues at University Hospital in Trondheim, Norway, documents a 41% verified failure rate after 4.7 years' follow-up in 123 patients who had meniscal repair using the Biofix Arrow.
"In our hands the failure rate is far too high, and others have reported similar experiences," Dr Drogset told CIAOMed. "Some people have now gone back to the old inside-out suture technique. We are also conducting a randomized, controlled trial to compare the Biofix Arrow with the newer Fast-Fix® method (Smith & Nephew, London, UK). Investigators at three hospitals will randomize a total of 150 patients between the two treatments. We hope to complete enrollment and all of the surgical procedures in the spring of 2007 and then will follow all patients for 2 years before we report results."
Dr Drogset told CIAOMed that the arrow technique had been adopted after 1997 as the standard procedure for meniscal repair in his hospital because early reports of 2- to 3-year follow-up showed success rates around 90%; success was owing to the fact that the method requires shorter operating time than does inside-out suturing (44 minutes in this study), and that it does not require open surgery with attendant damage to muscles and nerves. This study was done out of concern that longer follow-up might show different outcomes.
Time to Spike the Arrow?
Two other surgeons who reported problems with the Biofix Arrow agreed that the Fast-Fix method deserves more study, but both would have preferred to see it compared with the even newer Rapidloc® (DePuy Mitek, Raynham, Mass) or with "gold standard" inside-out suturing. Both the Fast-Fix and the Rapidloc are "all inside" suture-based approaches that do not require open incision.
David R. Diduch, MD, Professor of Sports Medicine at the University of Virginia in Charlottesville, Virginia, told CIAOMed, "We have moved away from using the Arrow. It may be that the whole class of rigid devices that dissolve, as the Arrow does, eventually will show outcome problems. Later failures might be because meniscus tears are partly healed, and it takes time after the Arrow dissolves for the patient to manifest problems. As the implant dissolves, its holding ability might diminish."
Dr Diduch, who is lead team physician for all University of Virginia athletic teams, also has concerns about the biomechanics of meniscus repair systems. "Another problem is that you can't adjust the tension across the repair with the Arrow, as you can with the Rapidloc. The advantages I see to the suture-based systems are that you can compress the tear more, put in multiple devices, and have a more flexible repair than with the rigid implants. Inside-out suture is still the gold standard, but the Fast-Fix oriented vertically is biomechanically just as strong as sutures. Oriented horizontally, it is not as strong. In my opinion, the use of the Arrow should be critically reassessed. There are better devices out there with equally good short-term healing rates."
Similarly, Peter R. Kurzweil, of the Southern California Center for Sports Medicine in Long Beach, California, told CIAOMed that comparing the Arrow with the Fast-Fix "makes no sense to me."
"You see my study with a high failure rate with the Arrow, then Dr Drogset finds the same thing," Dr Kurzweil said. "So how can you consider studying the Arrow again? How can you put a group of patients into [a study] knowing [the procedure] has a 40% failure rate? Compare Fast-Fix with the Rapidloc or sutures."
Dr Drogset explained to CIAOMed that one of the issues being addressed in the randomized trial is standardization of the Arrow procedure. The meniscus was rasped in only about half of the study patients, which may have contributed to failures. All of the meniscus repairs in the randomized trial will include preparing the meniscus with rasping or shaving.
Dr Kurzweil added that three more unanswered questions need examination. "Can we repair more complex tears, or tears in the avascular zone? Can we use biologics to stimulate or enhance healing? And what is the best rehab protocol post-op: accelerated or not?" he asked.
References
1. Gifstad T, Grontvedt T, Drogset JO. Meniscal repair with Biofix arrows. Results after 4.7 years' follow-up. Am J Sports Med. 2006;14 September 2006 [Epub ahead of print]
2. Lee GP, Diduch DR. Deteriorating outcomes after meniscal repair using the meniscus arrow in knees undergoing concurrent anterior cruciate ligament reconstruction. Increased failure rate with long-term follow-up. Am J Sports Med. 2006;33:1138-1141.
3. Kurzweil P, Tifford C, Ignacio E. Unsatisfactory clinical results of meniscal repair using the meniscus arrow. Arthroscopy. 2005;21:905.e1-905.e7.