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
The aim of this study was to compare the cost-effectiveness of
treatment with an osseointegrated percutaneous (OI-) prosthesis
and a socket-suspended (S-) prosthesis for patients with a transfemoral
amputation. A Markov model was developed to estimate the medical costs and
changes in quality-adjusted life-years (QALYs) attributable to treatment
of unilateral transfemoral amputation over a projected period of
20 years from a healthcare perspective. Data were collected alongside
a prospective clinical study of 51 patients followed for two years.Aims
Patients and Methods
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 osseointegrated percutaneous prostheses. Cite this article:
The first osseointegrated transfemoral amputation prosthesis operation was performed in Gothenburg in 1990. The aim is improving quality of life for patients who cannot use conventional socket prosthesis. In 1999 the prospective OPRA-study (Osseointegrated Prosthesis for Rehabiliation of Amputees) was initiated with standardized surgery, equipment and rehabilitation program. The surgery consists of a two-stage procedure. At the primary surgery (S1), a titanium screw (the fixture) is inserted into the remaining diaphyseal bone. The fixture is 80 mm long with a diameter of 16–20 mm (+0.5 mm increments). The patient is hospitalized 5-7 days. At the secondary surgery (S2), six months later, an abutment is inserted into the fixture. The abutment has a hexagonal press-fitting into the fixture and is secured by an abutment screw. The patient remains hospitalized 10–12 days. Gradual increase of load and activity is initiated over a 6 month period.Aim
Method
