Bone-anchored prostheses for transtibial amputation: A systematic review of outcomes, complications, and cost-effectiveness.

Abstract

To systematically review (following PRISMA guidelines) clinical outcomes and complications of transtibial osseointegration and identify benefits, risks, and knowledge gaps relevant to patients, clinicians, and policymakers. A systematic search of MEDLINE, Embase, APA PsycInfo, CINAHL, Cochrane Database of Systematic Reviews, PEDro, Health Technology Assessment, and NHS Economic Evaluation Database was conducted from inception to April 30, 2026. Based on a published a priori protocol, two independent reviewers evaluated articles on adults with transtibial amputation that compared outcomes before and after osseointegration surgery for any follow-up duration, with socket or no prosthesis as comparators. Of 3,823 articles screened, 19 met inclusion criteria, involving 102 individuals: 15 reported clinical outcomes (12 also reported complications), three focused solely on complications, and one examined cost-effectiveness. Study characteristics, outcomes data, adverse events, inclusion/exclusion criteria, and surgical/rehabilitation details were extracted. OCEBM Levels of Evidence were assigned and risk of bias was assessed via modified Downs and Black checklist for non-randomized studies and Drummond checklist for economic evaluations. Most studies were based on press-fit fixation and short follow-up (1-3 years). Reported benefits included improved health-related quality of life, mobility, and prosthesis use. Superficial infection was the most common adverse event, generally managed with oral antibiotics; serious complications, such as implant loosening leading to implant loss, were less common. No periprosthetic fractures or implant breakages were reported. No qualitative studies were found. The single cost-effectiveness study used estimated utilities and limited costs, restricting broader economic conclusions. Transtibial osseointegration shows potential to enhance quality of life, mobility, and prosthesis use for individuals unable to tolerate sockets but carries infection risks that necessitates careful management. Larger, long-term studies and health economic evaluations are needed to strengthen evidence for more informed clinical and policy decision-making.