The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis. In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years’ follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded.Aims
Methods
Aims. This study describes the Osseointegration Group of Australia’s
Accelerated Protocol two-stage strategy (OGAAP-1) for the osseointegrated
reconstruction of amputated limbs. Patients and Methods. We report clinical outcomes in 50 unilateral trans-femoral amputees
with a mean age of 49.4 years (24 to 73), with a minimum one-year
follow-up. Outcome measures included the Questionnaire for persons
with a Trans-Femoral Amputation, the health assessment questionnaire
Short-Form-36 Health Survey, the Amputation Mobility Predictor scores
presented as K-levels, 6 Minute Walk Test and timed up and go tests.
Adverse events included soft-tissue problems, infection, fractures
and failure of the implant. Results. Our results demonstrated statistically significant improvements
in all five outcome measures. A total of 27 patients experienced
adverse events but at the conclusion of the study, all 50 were walking
on
Patients with transfemoral amputation (TFA) often
experience problems related to the use of socket-suspended prostheses.
The clinical development of osseointegrated percutaneous prostheses
for patients with a TFA started in 1990, based on the long-term
successful results of osseointegrated dental implants. Between1999 and 2007, 51 patients with 55 TFAs were consecutively
enrolled in a prospective, single-centre non-randomised study and
followed for two years. The indication for amputation was trauma
in 33 patients (65%) and tumour in 12 (24%). A two-stage surgical
procedure was used to introduce a percutaneous implant to which
an external amputation prosthesis was attached. The assessment of
outcome included the use of two self-report questionnaires, the
Questionnaire for Persons with a Transfemoral Amputation (Q-TFA)
and the Short-Form (SF)-36. The cumulative survival at two years’ follow-up was 92%. The
Q-TFA showed improved prosthetic use, mobility, global situation
and fewer problems (all p <
0.001). The physical function SF-36
scores were also improved (p <
0.001). Superficial infection
was the most frequent complication, occurring 41 times in 28 patients
(rate of infection 54.9%). Most were treated effectively with oral
antibiotics. The implant was removed in four patients because of loosening
(three aseptic, one infection). Osseointegrated percutaneous implants constitute a novel form
of treatment for patients with TFA. The high cumulative survival
rate at two years (92%) combined with enhanced prosthetic use and
mobility, fewer problems and improved quality of life, supports
the ‘revolutionary change’ that patients with TFA have reported
following treatment with
