Removal of osteosynthesis materials (e.g. screws, plates, nails and wires) used to treat bone fractures

Prediger B, Mathes T, Pieper D
Record ID 32018000308
English
Original Title: Entfernung von osteosynthesematerialien (z.B. Schrauben, Platten, Nägel, Drähte), die zur behandlung von knochenbrüchen eingesetzt werden
Authors' objectives: Medical Background Osteosynthesis is the internal fixation of fractures by mechanical devices. After bone and soft tissue healing there is either the option to remove the osteosynthetic material or to leave it in place. In case the internal fixation causes symptoms such as pain or reduced physical functioning removal of the device is indicated. In contrast, elective removal of the osteosynthetic material in asymptomatic patients is a controversial surgical intervention.
Authors' results and conclusions: Results The systematic literature search identified ten eligible studies (1 RCT, 4 cohort studies, 5 before-after studies). No eligible studies containing economic, legal, social, ethical or organizational aspects associated with the technology were identified. All studies compared elective removal versus non-removal of osteosynthetic material. The implants regarded plates, screws, nails and/or staples. Implants were removed between 6 weeks and 27 months after surgery. The studies included a total of 410 patients. Primary and secondary efficacy and safety outcomes included functional mobility and pain scores, surgery related complications, quality of life, osteoarthritis and return to work. Follow-up ranged from 9 weeks to 31 months.
Authors' methods: Methods A systematic literature search was performed in Pubmed, Embase, EconLit, Cinahl and CENTRAL (10/2018). Central research question Is removal of osteosynthesis material in patients without medical indication (elective removal) effective in terms of complication rates, clinical/functional outcomes, health-related quality of life and cost effectiveness outcomes compared to retaining of the osteosynthesis material?
Authors' identified further research: Feasibility HTA Contractor: The contractor proposes to adapt the literature search strategy by removing the WHO strata and language limitations and excluding before-after studies. In order to refine the research question, the contractor proposes to include an additional research question that addresses the prognostic and predictive factors affecting the effectiveness of elective removal of the osteosynthetic material. Acknowledging these proposed changes, the contractor considers it possibly feasible to conduct a full HTA report on this topic. FOPH: The decision to conduct an HTA is predominantly based on quantity and quality of available evidence and cost saving potential. The overall body of evidence, as presented by the contractor, is considered small. The quality of the presented evidence appears moderate to low and the individual studies show large heterogeneity. Nonetheless, the presented evidence does not exclude that a more sensitive (e.g., on ankle fractures only) search strategy may detect sufficient evidence to conduct a meta-analysis and subsequent HTA. However, the relatively small potential budget impact per indication does not seem to justify conducting a full HTA.
Details
Project Status: Completed
URL for project: https://www.bag.admin.ch/bag/en/home/versicherungen/krankenversicherung/krankenversicherung-leistungen-tarife/hta/hta-projekte/osteosynthesematerialentfernung.html
Year Published: 2019
URL for published report: https://www.bag.admin.ch/dam/bag/en/dokumente/kuv-leistungen/leistungen-und-tarife/hta/berichte/h0012osme-scoping-report.pdf.download.pdf/h0012osme-scoping-report.pdf
URL for additional information: https://www.bag.admin.ch/bag/en/home/versicherungen/krankenversicherung/krankenversicherung-leistungen-tarife/hta/hta-programm.html
English language abstract: An English language summary is available
Publication Type: Other
Country: Switzerland
MeSH Terms
  • Fractures, Bone
  • Fracture Fixation, Internal
  • Minimally Invasive Surgical Procedures
  • Fracture Healing
  • Prostheses and Implants
  • Device Removal
  • Internal Fixators
  • Biocompatible Materials
Keywords
  • PROMs
  • efficacy
  • effectiveness
  • safety
  • costs
  • economics
  • cost-effectiveness
  • budget impact
  • legal
  • social
  • ethical
  • organisational
  • osteosynthetic material
  • osteosynthesis
  • fracture fixation
  • surgical intervention
Contact
Organisation Name: Swiss Federal Office of Public Health (FOPH)
Contact Address: Federal Office of Public Health, Schwarzenburgstrasse 157, CH-3003 Berne, Switzerland
Contact Name: Stephanie Vollenweider
Contact Email: hta@bag.admin.ch
Copyright: Swiss Federal Office of Public Health
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.