JBJS Supplement Cites New Findings from International Device Registries

Surgeons performed more than 1.1 million joint replacements in the US in 2011. That same year, the International Consortium of Orthopaedic Registries (ICOR) was launched to help close gaps in evidence and data collection related to orthopaedic implants. The ICOR network now consists of more than 70 stakeholders and more than 30 orthopaedic registries representing 14 nations.

The December 17, 2014 edition of The Journal contains an online supplement with 14 articles highlighting the achievements of international registries and the findings from 12 ICOR-initiated registry studies. The first article in the supplement (National and International Postmarket Research and Surveillance Implementation) summarizes the findings from the 12 registry studies. The second article (A Distributed Health Data Network Analysis of Survival Outcomes) provides an overview of the data extraction processes and analytic strategies used in the studies.

Key findings from the 12 studies contained in the supplement:

There were no differences in revision risk when metal-on-HXLPE (highly cross-linked polyethylene) implants with larger and smaller femoral head sizes were compared.

Non-cross-linked polyethylene was not associated with significantly worse revision outcomes when compared with metal-on-HXLPE.

Large-head-size metal-on-metal implants were associated with increased risk of revision after two years, compared with metal-on-HXLPE implants.

Use of ceramic-on-ceramic implants with a smaller head size was associated with a higher revision risk compared with metal-on-HXLPE implants and ceramic-on-ceramic implants with head sizes >28 mm.

When compared with hybrid fixation, cementless fixation was associated with an approximately 58% higher risk of revision surgery in patients aged 75 years or older.

Mobile-bearing, non-posterior-stabilized knee designs presented a 40% higher risk of failure than that found with fixed-bearing, non-posterior-stabilized designs.

Compared with fixed-bearing posterior-stabilized knee prostheses, patients who received mobile bearings had an 85% higher chance of revision within the first postoperative year.

Fixed non-posterior-stabilized (cruciate-retainin0 TKA performed better (with or without patellar resurfacing) than did fixed posterior-stabilized (cruciate-substituting) TKA.

Reported revision rates of TKA and THA among pediatric and young-adult patients is currently similar to that for older patients, but the dearth of data makes it incumbent on registries to continue collecting and analyzing data relevant to younger populations.

This systematic review and meta-analysis concluded that surgeons performing a primary THA should use an implant that outperforms benchmarks established by the UK’s National Institute for Health and Care Excellence (NICE).

Among 19 registry reports and 1052 articles examined, only one report and two studies mentioned patient-reported outcome measures (PROMs) and minimum clinically important differences in connection with revision rates after TKA or THA.

Successful collection of PROM data is possible with careful attention to selection of outcome measure(s) and minimizing the data-collection burden on physicians and patients.

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