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    Methods

    NICE identified studies and reviews relevant to direct skeletal fixation of limb prostheses using intraosseous transcutaneous implants from the medical literature. The following databases were searched between the date they started to 13.11.2023: MEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the internet were also searched (see the literature search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion.

    The following inclusion criteria were applied to the abstracts identified by the literature search.

    • Publication type: clinical studies were included with emphasis on identifying good quality studies. Abstracts were excluded if they did not report clinical outcomes. Reviews, editorials, and laboratory or animal studies, were also excluded and so were conference abstracts, because of the difficulty of appraising study methodology, unless they reported specific adverse events that not available in the published literature.

    • People with amputated upper or lower limbs.

    • Intervention or test: Direct skeletal fixation of limb prostheses using an intraosseous transcutaneous implant.

    • Outcome: articles were retrieved if the abstract contained information relevant to the safety, efficacy, or both.

    • If selection criteria could not be determined from the abstracts the full paper was retrieved.

    Potentially relevant studies not included in the main evidence summary are listed in the section on other relevant studies.

    Find out more about how NICE selects the evidence for the committee.

    Table 4 literature search strategy

    The following search strategy was used to identify papers in MEDLINE. A similar strategy was used to identify papers in other databases.

    Databases 

    Date searched 

    Version/files 

    MEDLINE ALL (Ovid) 

    13 out of 11/2023 

    1946 to November 10, 2023 

     

    EMBASE (Ovid) 

    13 out of 11/2023 

    1974 to 2023 November 10 

    EMBASE Conference (Ovid) 

     

     

    Cochrane Database of Systematic Reviews – CDSR (Cochrane Library) 

    13 out of 11/2023 

    Issue 11 of 12, November 2023 

    Cochrane Central Database of Controlled Trials – CENTRAL (Cochrane Library) 

    13 out of 11/2023 

    Issue 10 of 12, October 2023 

    International HTA database (INAHTA) 

    13 out of 11/2023 

    Trial sources searched November 2023

    • Clinicaltrials.gov

    • ISRCTN

    • WHO International Clinical Trials Registry

    Websites searched

    • National Institute for Health and Care Excellence (NICE)

    • NHS England

    • Food and Drug Administration (FDA) - MAUDE database

    • Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP – S)

    • Australia and New Zealand Horizon Scanning Network (ANZHSN)

    • General internet search

    MEDLINE search strategy

    1 Bone-Anchored Prosthesis/ 

    2 (Intraoss* adj4 Transcut* adj4 Amputat* adj4 Prosthes*).tw. 

    3 ITAP.tw. 

    4 (intraosse* or intra-osse* or intra osse*).tw. 

    5 Osseointegration/ 

    6 (osseointegrat* or osseoanchor* or OI).tw. 

    7 ((transcut* or transderm* or transhum* or bionic*) adj4 (implant* or prosthes*)).tw. 

    8 ((skeleta* or bone* or osseo*) adj4 (fixat* or anchor* or implant* or prosthes*)).tw. 

    9 ((Osseo* or Bone*) adj4 (prosthes* or implant*)).tw. 

    10 (bone* adj4 anchor* adj4 (prosthes* or implant*)).tw. 

    11 or/1-9 

    12 exp Amputation/ 

    13 exp Amputation Stumps/ 

    14 Amputation surgical/ 

    15 (Amputat* adj4 (limb* or digit* or finger* or thumb* or stump*)).tw. 

    16 (Disarticulat* or Hemipelvect*).tw. 

    17 or/12-15 

    18 11 and 17 

    19 OPRA Implant.tw. 

    20 OGAP-OPL.tw. 

    21 19 or 20 

    22 18 or 21 

    23 animals/ not humans/ 

    24 22 not 23 

    25 limit 24 to ed=20220901-20231130