Complications Associated with Use of the OPRA Protocol for Treatment of Transfemoral Amputation

Clinical Question

Background

The OPRA protocol for the utilization of bone-anchored suspension has been approved by the FDA for use in the prosthetic treatment of transfemoral amputation in the United States. Studies evaluating the benefits of using the OPRA protocol for bone-anchored prostheses have shown statistically significant improvement in quality of life (QoL) in patients who transitioned from conventional socket prostheses to a bone-anchored device after reported difficulties with conventional socket devices,^1,2 comparable general QoL scores for patients with a bone-anchored prosthesis when evaluated against a matched group of patients utilizing conventional socket prostheses,³ increased prosthesis use after implantation,^1,4,5 less patient-reported prosthesis associated problems compared to patients using conventional socket prostheses,³ improved spatiotemporal parameters compared to socket prostheses,⁶ and patient-reported improvements in their cognitive integration with their prosthesis following transition to a bone-anchored device.⁷ These findings are noteworthy suggesting bone-anchored prostheses are a viable alternative to socket prostheses for patients with transfemoral amputation. Recent research has also suggested that these improvements in QoL are sustained through long-term follow-up.⁴ However, studies have also reported various complications during the treatment and rehabilitation process. Practitioners need to be aware of these complications to maximize treatment outcomes, prevent barriers to bone-anchored prosthesis use, and reduce or avoid negative impacts on patient health.

Search Strategy

Synthesis of Results

Five studies were identified (see Evidence Table). Brånemark et al.¹ identified superficial infection, fixture removal, surgical revisions of the residual limb, deep infections, exchange of abutment and abutment screws, and accidental overload leading to abutment bending as complications during their five-year follow-up.

Hagberg et al.⁵ identified more than half of their patients had a mechanical complication after 15 years, with more active patients having higher incidence of mechanical complications. Hagberg et al.⁸ identified an increase in Severe Adverse Events (SAEs), events requiring medical treatment or hospitalization, in the second 5-year period of a 10 year follow-up, and more active patients had a higher incidence of mechanical complications.