The safety of one-stage versus two-stage approach to osseointegrated prosthesis for limb amputation

Abstract

Aims: Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach.

Methods: A comprehensive electronic search and quantitative data analysis from eligible studies were performed. Inclusion criteria were adults with a limb amputation managed with a one- or two-stage osseointegration procedure with follow-up reporting of complications.

Results: A total of 19 studies were included: four one-stage, 14 two-stage, and one article with both one- and two-stage groups. Superficial infection was the most common complication (one-stage: 38% vs two-stage: 52%). There was a notable difference in the incidence of osteomyelitis (one-stage: nil vs two-stage: 10%) and implant failure (one-stage: 1% vs two-stage: 9%). Fracture incidence was equivocal (one-stage: 13% vs two-stage: 12%), and comparison of soft-tissue, stoma, and mechanical related complications was not possible.

Conclusion: This review suggests that the one-stage approach is favourable compared to the two-stage, because the incidence of complications was slightly lower in the one-stage cohort, with a pertinent difference in the incidence of osteomyelitis and implant failure.

Fig. 1

The OPL (Osseointegration Prosthetic Limb) implant: image of the prosthetic components and schematic of the implant in a femur, from Osseointegration International.

Fig. 2

Diagrammatic representation of the electronic search strategy: keywords were based on the population (1 & 3), intervention (2), and outcome (4). Each box represents one line of the OVID advanced search string.

Fig. 3

Summary of systematic review: PRISMA flow diagram depicting article selection.

Fig. 4

Incidence of osteomyelitis with 95% confidence intervals: ● One-stage ■ Two-stage.

Fig. 5

Incidence of implant failure with 95% confidence intervals: ● One-stage ■ Two-stage.