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Guidelines for submissions

The data on the submission form incorporates the data supplied by third parties. It is carefully considered in good faith, and rating is granted by a Panel of experienced orthopaedic surgeons. ODEP rating is not designed to be part of the standard Regulatory approval process. Beyond Compliance, ODEP, Northgate Public Services, SCCL (Supply Chain Coordination Limited) and the surgeons involved do not accept liability for any errors or omissions which could affect the final ODEP rating.

  • Only one clinical series should be presented per pro-forma submission. The series may be single or multicentre. Repeated reports on a single series (e.g. publication of the same patient population in different journals) must be clearly identified.
  • Spreadsheet cells may be enlarged by increasing the row width. 
  • Do not merge cells or add new headings.
  • Fill in all fields. 
  • Where necessary use abbreviation NR (not reported) if the response is missing or undetermined or NA (not applicable) if the response is not required.

Reference Type

Peer reviewed journal
– published or accepted for publication in a peer reviewed journal

Conference presentation/poster – paper read or technical or scientific exhibit displayed at recognised academic conference

Available for peer review – other grey literature: unpublished/unaccepted manuscripts, internal company reports, company registry report, company white papers, internet articles where full text is available for peer review on request by the reviewers
  Reference   Full bibliographic/reference details
  Prosthesis details   Brand name.  Where more than one variant is available under the brand name, the variant being reported must be clearly identified. Prosthetic combinations (stem/head/liner/cup/cement) should be clearly stated.  
  Design Changes
  Any design changes compared to currently marketed product must be declared.  
  Study details

Number of centres

Number of surgeons

Clinical setting

Product developers series

number of participating centres in the study will generally be the number of consultant grade surgeons

participating in the study, although if the numbers of operating surgeon grades  is available for consultant and trainees this may be reported

Teaching hospital(s)/General hospital(s)/Teaching and General hospitals

Indicate if the report is from the surgeon developers of the implant or is independent centre(s) or a mixture
  Study design
  RCT – randomised controlled trial

Comparative study – cohort study with prospective or historical controls

Unselected consecutive cohort – pragmatic all patients implanted cohort

Selected cohort – non-consecutive cohort, some patients excluded from reporting

National/Regional registry – independent registry data
  Patients and Results   Original number of patients in study  – number of patients originally enrolled in study (or reported in an earlier study)

Number of implants at start of study – number of hip originally implanted  in study (or reported in an earlier study)

Number of implants lost due to patients death – implants withdrawn from study through death

Number of implants lost to follow-up –implants where outcome is unknown at reported follow-up period

Number of implants revised for any reason – all component revisions

Number of implants surviving at end of study – number of intact implants theoretically available for review

Number of patients examined – patients actually reviewed in person (e.g. in clinic)

Number of patients questionnaire/telephone review – patients not reviewed in person

Mean follow-up and range –  for this report
  Revisions   Revisions – should add up to total reported above
  Kaplan-Meier Survival Curves   Follow-up period – duration of Kaplan-Meier survivorship

Kaplan-Meier Survival Curves – Since the right hand side of the K-M curve has potentially the least information and greatest uncertainty, it is important that the 95% confidence intervals are reported.

  Comments   This box is provided for any additional commentary on the study results or data that may be needed to better understand the data.  

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