Background: For almost 30 years, bone-anchored prostheses have offered an alternative solution to prosthetic sockets by attaching the artificial limb directly to the femoral residuum by means of an osseointegration implant. Osseointegration implant surgery was introduced in our center in 2009. The aim of the present study is to report on safety, prosthesis-wearing time, and health-related quality-of-life (HRQoL) for patients with femoral bone-anchored prostheses during a 5-year follow-up period. Methods: All patients who underwent implantation of a press-fit osseointegration implant between May 2009 and November 2013 were eligible for the present study. Implantation was performed in 2 stages. Adverse events included infectious complications (grade 1 to 4), aseptic loosening, breakage, stoma-redundant tissue, and stoma hypergranulation. Prosthesis-wearing time and HRQoL were measured with the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) prosthetic use score and global score, respectively. Results: Thirty-nine of 42 eligible patients were included. Thirty patients (77%) presented with some kind of infection (156 events in total), with 148 (95%) events being classified as grade 1 or 2 and 8 events (5%) being classified as grade 3; the latter 8 events occurred in 4 patients. There were no instances of septic loosening. The intramedullary stem of the osseointegration implant broke in 2 patients. In total, soft-tissue refashioning had to be done 30 times in 14 patients. The Q-TFA median prosthetic use and global scores improved significantly from 71 to 100 and from 33 to 75, respectively (p < 0.001). Conclusions: Despite the adverse events, patient prosthetic use and HRQoL improved significantly. Grade-1 and 2 infections were frequent but could mostly be treated with nonoperative measures. Most infections seemed to occur in the first 2 years and did not lead to deep infections. Two broken intramedullary stems were revised successfully. Current developments focus on reduction of infectious complications and prevention of osseointegration implant breakage. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

BackgroundThis study aimed to provide an overview of device-related complications occurring in individuals with an upper or lower extremity amputation treated with a screw, press-fit or other type of bone-anchored implant as well as interventions related to these complications.MethodA systematic literature search was conducted in the MEDLINE, Cochrane, EMBASE, CINAHL and Web of Science databases. The included studies reported on device-related complications and interventions occurring in individuals with bone-anchored prostheses. The outcomes evaluated were death, infection, bone/device breakage, implant loosening, soft tissue complications, systemic events, antibiotic and surgical treatment. Subgroup analyses were performed for the following groups: a) implant type (screw, press-fit and other types of implants) and b) level of amputation (transfemoral, transtibial and upper extremity amputation).ResultsOf 309 studies, 12 cohort studies were eligible for inclusion, all of which had methodological shortcomings and 12 studies were excluded due to complete overlap of patient data. Implant infection were rare in certain transfemoral implants (screw: 2–11%, press-fit: 0–3%, Compress: 0%) but common in transtibial implants (29%). The same was observed for implant loosening, in transfemoral (screw: 6%, press-fit: 0–3%, Compress: 0%), transtibial implants (29%) as well as for upper extremity implants (13–23%). Intramedullary device breakage were rare in transfemoral implants (screw: 0%, press-fit: 1%, Compress: unknown) but frequent in individuals with transradial implants (27%) and absent in transtibial implants. Soft tissue infections and complications were common and underreported in most articles.ConclusionsMajor complications (e.g. implant infection, implant loosening and intramedullary device breakage) are rare in transfemoral bone-anchored prosthesis and seem to occur less frequently in individuals with press-fit implants. Minor complications, such as soft tissue infections and complications, are common but are substantially influenced by the learning curve, implant design and surgical technique. Data for patients treated with a transtibial, upper extremity or Compress implant are underreported, precluding definitive conclusions. There is a need for either an international database to report on or a standard core set of complications as well as the need to follow classification systems that result in unequivocal data.

There is a need for a standard set of instruments. There was limited evidence that bone-anchored prostheses resulted in higher QoL, function and activity levels than socket prostheses, in patients with socket-related problems. Implications for Rehabilitation Use of bone-anchored prostheses in combination with intensive outpatient rehabilitation may improve QoL, function and activity level compared with socket prosthesis use in patients with a transfemoral amputation and socket-related problems. All clinicians and researchers involved with bone-anchored prostheses should use and publish data on QoL, function, activity and participation level. There needs to be an agreement on a standard set of instruments so that interventions for patients with a lower extremity amputation are assessed consistently.

Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Background We described safety and functional one-year follow-up outcomes of individuals with lower limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants. Methods All consecutive individuals treated between March 2015 and June 2018 with curved osseointegration femur implant (OFI-C) indicated for a long femoral remnant, gamma osseointegration femur implant (OFI-Y) indicated for a short femoral remnant, or osseointegration tibia implant (OTI) were eligible for this study. All adverse events were evaluated, infections were graded as follows: grade 1 and 2: low-and high-grade soft tissue infection, respectively, grade 3: deep bone infection, grade 4: septic implant failure. Functional outcome measures included prosthesis wearing time (PUS), health-related quality of life (GS), and the overall situation as an amputee (GS Q3); evaluated with the Questionnaire of persons with trans-femoral amputation (Q-TFA) before surgery and at one-year follow-up. Results Ninety of 91 individuals were included (mean age: 54±14 yrs, 26 females); treated with 53, 16 and 21 OFI-C, OFI-Y and OTI, respectively. Soft tissue infections (grade 1: 11 events, grade 2: 10 events) were treated successfully with antibiotics except in two (OFI-C and OFI-Y), who required additional surgery due to recurrent stoma irritation and peri-stoma abscess drainage. One individual with dysvascular amputation (OTI) developed septic implant loosening and occlusion of the femoral artery resulting in a transfemoral amputation. No aseptic

Objectives:(1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events.Design:Prospective cohort study.Setting:University medical centre.Subjects:A total of 40 consecutive persons (median age: 56 years) who received a transfemoral (31) or transtibial (9) osseointegration implant, between April 2014 and March 2016.Intervention:Osseointegration implant surgery followed by a predefined rehabilitation programme.Main measures:Hip abductor strength, prosthetic use, back pain frequency, postoperative pain, mobility level (Timed-Up and Go (TUG) and wheelchair-boundedness), walking ability (6 minute walking test (6MWT) and walking distance in daily life), HRQoL, satisfaction regarding the prosthesis, and adverse events.Results:Strength, prosthetic use, walking distance, HRQoL, and satisfaction level increased significantly at 6- and 12-month follow-up compared to baseline (P ⩽ 0.002). The TUG showed no change at 6-month follow-up (P = 0.420) but improved significantly at 12-month follow-up compared to baseline (P = 0.005). Wheelchair-boundedness decreased from 12/40 participants at baseline to 0 at follow-ups. The 6MWT (P ⩾ 0.038) and back pain (P ⩾ 0.437) did not change over time. Stump pain was present in 28/39 and 22/40 of the participants at 6-and 12-month follow-up, respectively. The major adverse events were managed successfully and included three dual-cone breakages and four bone fractures. An uneventful course was completed by 19/31 transfemoral and 4/9 transtibial bone-anchored prostheses users.Conclusion:Bone-anchored prostheses lead to improved performance and appear to be safe, so they might be considered for persons with socket-related problems.

This article reviews the development of multidisciplinary osseointegration treatment in the Netherlands since its start in 2009. People experiencing limitations due to their socket prosthesis after a leg amputation present to the Radboud University Nijmegen Medical Centre for an osseointegration implant or “bone-anchored” prosthesis. In this article we share our experience with the first 100 patients regarding referral pattern, selection criteria, available osseointegration systems, preoperative planning, surgical treatment, the rehabilitation protocol, outcome measurement, revision surgery, and future developments.

Background: In patients with a transfemoral amputation socket-related problems are associated with reduced prosthetic use, activity, and quality of life. Furthermore, gait asymmetries are present that may explain secondary complaints. Bone-anchored prostheses (BAPs) may help these patients. Two types of BAP are available, screw and press-fit implants. Rehabilitation following surgery for a press-fit BAP is poorly described. Purpose: To describe a rehabilitation program designed to minimize compensation strategies and increase activity using a case-report of an active, 70-year-old man with a traumatic transfemoral amputation who had used a socket prosthesis for 52 years and received a press-fit BAP [Endo-Exo Femoral Prosthesis -EEFP]. Intervention: A 13-week physiotherapy program. Outcomes: Outcomes were assessed before surgery, at the end of rehabilitation, and six-month and one-year follow-ups. After rehabilitation gait had improved, the patient had more arm movement, more pelvic shift, less hip rotation during swing phase on the prosthetic side, and absence of vaulting on the sound side. Isometric hip abductor strength was 15% higher on the sound side and 16% higher on the prosthetic side, and walking distance increased from 200 m to 1500 m. At the six-month follow-up, the patient had lower back complications and reduced hip abductor strength and walking distance. At oneyear follow-up, walking distance had recovered to 1000 m and gait pattern had improved again, with yielding and absence of terminal impact on the prosthetic side. Conclusion: The described rehabilitation program may be an effective method of improving gait in patients with an EEFP even after long-term socket usage.