Safety and Performance of Bone-Anchored Prostheses in Persons with a Transfemoral Amputation

Abstract

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.

Extramedullary Osseointegration—A Novel Design of Percutaneous Osseointegration Prosthesis for Amputees

“…In the 5-year follow-up of the 51 patients with OPRA implants, 70 superinfections occurred in 34 patients (67%) and 14 deep infections occurred in 11 patients (22%) ( Branemark et al, 2019 ). The results are similar to the 5-years retrospective study on 39 patients using the press-fit implants, in which thirty patients (77%) presented with 156 events of superficial infections in total, with eight events (5%) in 4 patients being classified as deep infections ( Reetz et al, 2020 ).…”

“…In the OPRA cohort, the abutment and/or abutment screw fractures occurred in 15 of the 51 patients (29%) within 5 years ( Branemark et al, 2019 ). Among the 39 patients using the ILP system, nine patients (23%) got 12 dual-adaptor breakages in 5 years ( Reetz et al, 2020 ). A long-term follow-up of 111 patients using the OPRA system indicates that mechanical complications dramatically increased after 8 years of OPRA usage.…”

CORR Insights®: What Are the Risk Factors for Mechanical Failure and Loosening of a Transfemoral Osseointegrated Implant System in Patients with a Lower-limb Amputation?

“…Taking a closer look, what they really reported was one deep infection (2%), six fractures of (generally smaller-diameter) intramedullary stems (10%), and 13 broken transcutaneous dual cone adapters (22%). Earlier reports from these authors and others [1,12], including many of the same patients at earlier time points, reported a lower frequency of mechanical problems (as might be expected with shorter follow-up) and frequent minor soft tissue infections but demonstrated improved prosthesis use and health-related quality of life. The stem fracture rates are higher than might be expected or hoped for, and the authors attribute this to smaller diameter stems and an increased number of infectious events.…”

Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products

“…9 Today, bone-anchored prostheses (BAPs), directly attached to a percutaneous implant, have become an alternative to socketsuspended prostheses (SSPs), especially in patients who have undergone transfemoral amputation (TFA) for reasons other than vascular disease and who have difficulty obtaining adequate and comfortable socket suspension. [10][11][12][13] Among patients using BAPs, improvements in patient-reported outcomes with regard to prosthetic function and HRQL have been reported as compared to their previous situation, [14][15][16][17][18] although in conjunction with implantrelated complications. 14,[17][18][19][20][21] Health economic evaluations of BAPs have shown higher costs, fewer visits, and some gain of qualityadjusted life-years (QALYs) as measured by the use of SF-36/SF-6D and as compared to the SSPs.…”