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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Methods

    NICE identified studies and reviews relevant to biodegradable subacromial spacer insertion for rotator cuff tears from the medical literature. The following databases were searched between the date they started to 12/12/22: MEDLINE, PREMEDLINE, 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.

    • Patients with rotator cuff tears.

    • Intervention or test: biodegradable subacromial spacer insertion.

    • 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

    Databases

    Date searched

    Version/files

    MEDLINE (Ovid)

    12/12/2022

    1946 to December 07, 2022

    MEDLINE In-Process (Ovid)

    12/12/2022

    1946 to December 06, 2022

    MEDLINE Epubs ahead of print (Ovid)

    12/12/2022

    December 06, 2022

    EMBASE (Ovid)

    12/12/2022

    1974 to 2022 December 09

    EMBASE Conference (Ovid)

    12/12/2022

    1974 to 2022 December 09

    Cochrane Database of Systematic Reviews – CDSR (Cochrane Library)

    12/12/2022

    Issue 12 of 12, December 2022

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

    12/12/2022

    Issue 11 of 12, November 2022

    International HTA database (INAHTA)

    12/12/2022

    -

    Trial sources searched:

    • 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.

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

    MEDLINE search strategy

    Strategy used:

    1 Rotator Cuff/

    2 Shoulder Impingement Syndrome/

    3 Shoulder Pain/

    4 Shoulder Joint/

    5 Acromion/

    6 (shoulder* or rotat* or rotor* or rotar* or cuff* or humer* or abcromi* or subacromi* or sub-acromi* or arthroscop* or supraspinatus* or infraspinatus* or "teres minor*" or teres-minor* or subscapularis*).ti,ab.

    7 ((scar* or tear* or torn* or rip* or ruptur* or absenc* or irrepair* or irreparab* or imping* or non-funct* or nonfunct* or ruptur*) adj4 (lesion* or large* or partial* or massive* or tendon* or tendin* or ligament* or muscle* or coracohumeral* or coracoid* or internal* or posterosuperio* or outlet* or glenohumeral* or fullthick* or full-thick* or glenoid*)).ti,ab.

    8 or/1-6

    9 7 and 8

    10 Arthroplasty, Replacement, Shoulder/ or Arthroplasty, Replacement/ or Arthroplasty/

    11 (arthroplast* or arthroscop* or fluoroscop*).tw.

    12 Video-Assisted Surgery/

    13 Surgery, Computer-Assisted/

    14 Therapy, Computer-Assisted/

    15 ((minimal* or non*) adj4 invasiv* adj4 (surg* or tech* or treat* or therap* or device* or procedure*)).tw.

    16 ((video* or comput*) adj4 (surg* or tech* or treat* or therap* or device* or pocedure*)).tw.

    17 or/10-16

    18 Polymers/

    19 Biodegradable Plastics/

    20 (compostab*or copolymer* or co-polymer* or polymer* or biodegrad* or biograd* or saline* or fluid* or absorb*).ti,ab.

    21 joint prosthesis/ or shoulder prosthesis/

    22 Absorbable Implants/

    23 (implant* or space* or balloon*).ti,ab.

    24 or/18-23

    25 9 and 17 and 24

    26 (Inspace or inspaceTM or Orthospace).ti,ab.

    27 25 or 26

    28 animals/ not humans/

    29 27 not 28