A new study describes the results of a systematic literature
search of device-related complications in people with amputations who
were treated with a bone-anchored prosthetic device. The researchers who
conducted the study searched the MEDLINE, Cochrane, EMBASE, CINAHL, and
Web of Science databases, and included studies that 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, and antibiotic and surgical treatment.
Subgroup analyses were performed for the following groups: implant type
(screw, press-fit and other types of implants) and level of amputation
(above-knee, below-knee, and upper-limb).
Of 309 studies, 12
cohort studies were eligible for inclusion, all of which had
methodological shortcomings, according to the study’s authors. The
eligible articles described 537 individuals with a lower-limb amputation
and 67 individuals with an upper-limb amputation, who were treated with
bone-anchored prostheses in eight centers worldwide.
team found that implant infections were rare in certain above-knee implants (screw 2-11 percent, press-fit 0-3 percent, Compress 0 percent)
but common in below-knee implants (29 percent). The same was observed
for implant loosening in above-knee implants (screw 6 percent,
press-fit 0-3 percent, Compress 0 percent), below-knee implants (29
percent), and upper-limb implants (13-23 percent).
device breakage was rare in above-knee implants (screw 0 percent,
press-fit 1 percent, Compress unknown) but frequent in individuals with below-elbow implants (27 percent) and absent in below-knee implants.
Soft tissue infections and complications were common and underreported
in most articles, according to the authors.
(e.g. implant infection, implant loosening, and intramedullary device
breakage) were rare in above-knee bone-anchored prosthesis and seemed
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 for the
treatment and adaptation of technique, implant design, and surgical
The researchers noted that data for patients treated
with a below-knee, upper-limb, or Compress implants are underreported,
which precludes definitive conclusions. They suggest that there is a
need for either an international database to report on complications or a
standard core set of complications, as well as the need to follow
classification systems that result in unequivocal data.
The open-access study was published August 9 in PLOS One.