Improvements in disability and function in people with lower-limb amputation one year after prosthesis osseointegration

Abstract

Background: People with lower-limb amputation (LLA) are routinely prescribed a socket prosthesis; however, many socket prosthesis users experience severe complications with the fit of their prosthesis including residual limb wounds and pain. Osseointegration is a procedure that creates a direct connection between the bone and prosthetic limb through a bone-anchored prosthesis, eliminating the need for a socket interface. It is offered as a secondary procedure to people with LLA who experience significant complications with socket prostheses. Objectives: To evaluate change in disability and function 1 year postosseointegration compared with preosseointegration in people with LLA. Study design: Single group, pretest, and post-test. Methods: Twelve participants (9 transfemoral and 3 transtibial amputations, age: 44 6 10 years, 7 female participants, 14 6 12 years since amputation) with unilateral LLA underwent osseointegration with press-fit implants. Disability was measured with the World Health Organization Disability Assessment Schedule 2.0, and function was measured with both Prosthetic Limb Users Mobility Survey and the Activities-Specific Balance Confidence Scale. Questionnaires were administered preosseointegration and 1 year postosseointegration. Paired t tests assessed change in outcomes between time points. Results: Postosseointegration, participants demonstrated reduced disability measured with World Health Organization Disability Assessment Schedule 2.0 (%D 5 252.6, p 5 0.01), improved mobility measured with Prosthetic Limb Users Mobility Survey (%D 5 21.8, P , 0.01), and improved balance confidence measured with the Activities-Specific Balance Confidence Scale (%D 5 28.4, P , 0.01). Conclusions: Participants report less disability and greater function in their prosthesis postosseointegration. Osseointegration is a novel procedure for people experiencing complications with their socket prosthesis, and this study is the first to show improvements in disability postosseointegration.

Bone-anchored prostheses for transfemoral amputation: a systematic review of outcomes, complications, patient experiences, and cost-effectiveness

“…Similarly, there were no significant differences in these measures between 5- and 10-year follow-ups ( 50 ). A significant reduction in disability (as measured by the WHODAS 2.0) was also reported at 1-year follow-up ( 63 ).…”

“…Prosthesis use as measured by Q-TFA prosthetic use score was reported to have increased significantly at 1-year ( 28 , 55 , 58 ), 2-year ( 44 , 45 ), 5-year ( 46 , 47 , 52 ), and 10-year ( 50 ), but not at 15-year ( 49 ), follow-up. Improved perceived mobility (measured by PLUS-M), balance (measured by ABC), and functional capacity were also reported at 1-year follow-up ( 63 ), as were significant reductions in time to don and doff the prosthesis ( 62 ).…”

“…Table 2 shows the inclusion and exclusion criteria in each of the included studies. The most common inclusion criteria are recurrent problems or the inability to use socket prostheses ( 28 , 44 – 52 , 54 – 58 , 63 ), mature skeleton ( 28 , 44 , 45 , 47 – 49 , 52 ), or normal residual skeletal anatomy ( 44 , 45 , 47 ), the ability to comply with the treatment and follow-up requirements ( 45 – 48 , 52 , 54 , 56 , 62 ), and pre-surgical evaluation by a clinical team ( 44 , 46 , 51 , 52 , 57 , 63 ) along with physical and medical examinations and imaging ( 44 , 45 , 47 ). There also are several contraindications to the OI surgery.…”

“…There also are several contraindications to the OI surgery. The most common exclusion criteria are severe peripheral vascular disease ( 44 – 47 , 49 – 52 , 54 , 56 , 57 ), diabetes mellitus ( 28 , 44 – 46 , 49 – 52 , 54 , 56 , 57 , 62 ), treatment with chemotherapy ( 44 – 46 , 49 , 50 , 52 , 54 , 56 , 57 , 63 ), exposure of the amputated limb to radiation ( 28 , 52 , 54 , 56 – 58 , 63 ), current treatment with corticosteroids ( 44 – 46 ) or immunosuppressive drugs ( 28 , 54 , 56 , 57 , 62 ), and pregnancy ( 44 – 46 , 54 , 56 ). The most common age range reported for patient selection in the included studies was between 18 and 70 years.…”

“…All types of implants (screw-type or press-fit type) showed an improvement to varying degrees in HRQoL, mobility, and prosthesis usage when the pre-surgical condition (with socket prosthesis) of the patients is compared to their postsurgical condition. Most studies were based on the duration of follow-up of 1 year ( 28 , 48 , 51 , 54 – 56 , 58 , 62 , 63 ) or 2 years ( 44 , 45 , 57 ) post-intervention. There were three studies based on a 5-year follow-up ( 46 , 47 , 52 ) and one study each for 10-year ( 50 ) and 15-year ( 49 ) follow-ups, respectively, post-intervention.…”