Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications

Hagberg, Kerstin; Jahani, Shadi Afarin Ghasemi; Omar, Omar; Thomsen, Peter

doi:10.1016/j.jot.2022.09.004

Cited by 13 publications

(26 citation statements)

References 39 publications

(56 reference statements)

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“…Compared to baseline, an improvement in SF-36 physical component score (PCS) was reported at 1-year ( 54 , 56 ), 2-year ( 44 – 47 , 57 ), 5-year ( 46 , 47 ), and 10-year ( 50 ) follow-ups. The SF-36 mental component score (MCS), however, was reported to have improved at a 2-year ( 57 ) follow-up in one study but did not consistently show improvements in other studies.…”

Section: Resultsmentioning

confidence: 99%

“…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.…”

Section: Resultsmentioning

confidence: 99%

“…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.…”

Section: Resultsmentioning

confidence: 99%

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

Rehani,

Stafinski,

Round

et al. 2024

Front. Rehabil. Sci.

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IntroductionBone-anchored prostheses (BAP) are an advanced reconstructive surgical approach for individuals who had transfemoral amputation and are unable to use the conventional socket-suspension systems for their prostheses. Access to this technology has been limited in part due to the lag between the start of a new procedure and the availability of evidence that is required before making decisions about widespread provision. This systematic review presents as a single resource up-to-date information on aspects most relevant to decision makers, i.e., clinical efficacy, safety parameters, patient experiences, and health economic outcomes of this technology.MethodsA systematic search of the literature was conducted by an information specialist in PubMed, MEDLINE, Embase, CINAHL, Cochrane Library, the Core Collection of Web of Science, CADTH's Grey Matters, and Google Scholar up until May 31, 2023. Peer-reviewed original research articles on the outcomes of clinical effectiveness (health-related quality of life, mobility, and prosthesis usage), complications and adverse events, patient experiences, and health economic outcomes were included. The quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine Levels of Evidence and ROBINS-I, as appropriate.ResultsFifty studies met the inclusion criteria, of which 12 were excluded. Thirty-eight studies were finally included in this review, of which 21 reported on clinical outcomes and complications, 9 case series and 1 cohort study focused specifically on complications and adverse events, and 2 and 5 qualitative studies reported on patient experience and health economic assessments, respectively. The most common study design is a single-arm trial (pre-/post-intervention design) with varying lengths of follow-up.DiscussionThe clinical efficacy of this technology is evident in selected populations. Overall, patients reported increased health-related quality of life, mobility, and prosthesis usage post-intervention. The most common complication is a superficial or soft-tissue infection, and more serious complications are rare. Patient-reported experiences have generally been positive. Evidence indicates that bone-anchored implants for prosthesis fixation are cost-effective for those individuals who face significant challenges in using socket-suspension systems, although they may offer no additional advantage to those who are functioning well with their socket-suspended prostheses.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

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

Rehani,

Stafinski,

Round

et al. 2024

Front. Rehabil. Sci.

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“…Discomfort associated with prosthetic sockets 4 can be overcome with POI which transfer load directly to the bone and significantly improve the quality of life for those with TFA. 5 Despite the functional gains of an osseointegrated connection, adverse events related directly and indirectly to POI have influenced mainstream uptake. We propose that this is in part due to non-standardised reporting of adverse events and quantification of implant/bone integration and long term bone fixation success.…”

Section: Introductionmentioning

confidence: 99%

A scoring system to evaluate stability of percutaneous osseointegrated implants for transfemoral amputation with validation in the ITAP clinical trial

Ahmed,

Blunn

2024

Proc Inst Mech Eng H

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Percutaneous osseointegrated implants for individuals with lower limb amputation can increase mobility, reduce socket related pain, and improve quality of life. It would be useful to have an evaluation method to assess the interface between bone and implant. We assessed outpatient radiographs from the Intraosseous Transcutaneous Amputation Prosthesis clinical trial using an interface scoring system which summed and weighted equally measures of implant collar cortical ongrowth and radiolucency along the implant stem/bone interface. Radiographs from 12 participants with unilateral transfemoral amputations (10 males, 2 females, mean age = 43.2, SD = 7.4 years) in the clinical trial from cohort I (implanted in 2008/09) or cohort II (implanted in 2013/14) were collated (mean image span = 7.2, SD = 2.4 years), scale normalised, zoned, and measured in a repeatable way. Interface scores were calculated and then compared to clinical outcomes. Explanted participants received the lowest interface scores. A higher ratio of stem to residuum and shorter residuum’s produced better interface scores and there was an association (weak correlation) between participants with thin cortices and the lowest interface scores. A tapered, cemented, non curved stem may provide advantageous fixation while stem alignment did not appear critical. In summary, the interface score successfully demonstrated a non-invasive evaluation of percutaneous osseointegrated implants interfaces when applied to the Intraosseous Transcutaneous Amputation Prosthesis clinical trial. The clinical significance of this work is to identify events leading to aseptic or septic implant removal and contribute to clinical guidelines for monitoring rehabilitation, design and surgical fixation choices.

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“…showed that PROs were improved after the introduction of a novel principle for bone anchorage of amputation prostheses. However, an increasing rate of mechanical complications was of concern [ 7 ]. While the teriparatide (PTH (1–34)) is a potent bone anabolic drug for osteoporosis, it also exhibited marked chondroprotective effect in the study by Li et al.…”

mentioning

confidence: 99%

2023 January issue Journal of Orthopaedic Translation

Xiao¹

2023

Journal of Orthopaedic Translation

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Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications

Cited by 13 publications

References 39 publications

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

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

A scoring system to evaluate stability of percutaneous osseointegrated implants for transfemoral amputation with validation in the ITAP clinical trial

2023 January issue Journal of Orthopaedic Translation

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