407 JRRD JRRD Volume 52, Number 4, 2015 Pages 407–420 Fifteen years of experience with Integral-Leg-Prosthesis: Cohort study of artificial limb attachment system Dora-Lisa Juhnke, MD; 1 James P. Beck, MD; 2 Sujee Jeyapalina, PhD; 3 Horst H. Aschoff, MD 4* 1 Klinik für Allgemein-, Gefäß-, und Viszeralchirurgie, Martin-Luther-Krankenhaus, Berlin, Germany; 2 Department of Orthopaedics, University of Utah School of Medicine, and Department of Veterans Affairs Salt Lake City Health Care System, Salt Lake City, UT; 3 Department of Bioengineering, University of Utah, Salt Lake City, UT; 4 Clinic for Plastic, Hand, and Reconstructive Surgery, SANA Kliniken Lübeck, Lübeck, Germany Abstract—Integral-Leg-Prosthesis (ILP) is a comparatively new attachment system that allows direct skeletal docking of artificial limbs. Between January 1999 and December 2013, 69 patients with transfemoral amputation were fitted with ILPs by a single German surgeon. Device design iterations and sur- gical techniques evolved during these years. For the purposes of comparison, patients receiving the first two designs and pro- cedure iterations were placed in group 1 and the patients fitted with the final design were placed in group 2. Infection rate and planned and unplanned surgical interventions were statistically compared using Fisher exact test. Data demonstrated that the high rate of stoma-associated infections seen in group 1 was dramatically reduced in group 2. Of the 39 patients with 42 implants in group 2, none had operative interventions second- ary to infection. All group 2 patients remained infection-free without the use of antibiotics by following a simple but defined wound-hygiene protocol. We concluded that the final iteration of the osseointegrated intramedullary device with a low energy surface at the soft tissue and prosthesis interface allowed a bio- logically stable skin stoma that remained infection-free without chronic use of antibiotics. The reduction in the infection rate was attributed to the clinically based, empirically driven changes in design and surgical techniques. Key words: above-knee amputation, amputation, device design, infection rate, Integral-Leg-Prosthesis, osseointegrated prosthe- sis, prosthesis, skeletal docking system, titanium niobium oxyni- tride surface coating, transfemoral amputation. INTRODUCTION The loss of a limb is associated with inescapable end- stage disease or complex musculoskeletal trauma. The con- ventional means of exoprosthetic attachment, the centuries- old socket method of prosthetic suspension, is sometimes suboptimal, especially in cases of young and otherwise active patients with multiple amputations and/or short residual limbs. Obesity, which is further exacerbated by diminished ability to exercise, makes it difficult to fit socket suspension because of redundant fatty soft tissue. Even in patients with a normal body mass index, innovations in socket designs and liner materials are commonly unable to compensate for the intrinsically less than ideal physics and physiology of attaching an artificial limb to the vulnerable soft tissue envelope containing the remaining residual limb bone. Often, the final outcome, particularly for multiple amputations and/or short residual limbs, is accepting a life confined to a wheelchair. Abbreviations: HIPAA = Health Insurance Portability and Accountability Act, ILP = Integral-Leg-Prosthesis, [Ti,Nb]ON = titanium niobium oxynitride. * Address all correspondence to Horst H. Aschoff, MD; SANA Kliniken Lübeck, Clinic for Plastic, Hand, and Reconstruc- tive Surgery, Kronsforder Allee 71-73, 23560 Lübeck, Ger- many; +49 451 585 1305. Email: horst.aschoff@sana.de http://dx.doi.org/10.1682/JRRD.2014.11.0280