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Bone & Joint Research
Vol. 5, Issue 6 | Pages 206 - 214
1 Jun 2016
Malak TT Broomfield JAJ Palmer AJR Hopewell S Carr A Brown C Prieto-Alhambra D Glyn-Jones S

Objectives. High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA). Methods. We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA. Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines. We conducted a search of Medline and Embase (OVID) databases. Separate search strategies were devised for the Cochrane database and Google Scholar. Each search was performed to include articles from the date of their inception to June 8, 2015. Results. Our search strategy identified 1082 studies of which 115 studies were included for full article review. Following review, 17 articles were found that investigated surrogate markers of long-term outcome. These included one systematic review, one randomised control trial (RCT), one case control study and 13 case series. Validated surrogate markers included Radiostereometric Analysis (RSA) and Einzel-Bild-Röntgen-Analyse (EBRA), each measuring implant migration and wear. We identified five RSA studies (one systematic review and four case series) and four EBRA studies (one RCT and three case series). Patient Reported Outcome Measures (PROMs) at six months have been investigated but have not been validated against long-term outcomes. Conclusions. This systematic review identified two validated surrogate markers of long-term primary THA outcome: RSA and EBRA, each measuring implant migration and wear. We recommend the consideration of RSA in the pre-market testing of new implants. EBRA can be used to investigate acetabular wear but not femoral migration. Further studies are needed to validate the use of PROMs for post-market surveillance. Cite this article: T. T. Malak, J. A. J. Broomfield, A. J. R. Palmer, S. Hopewell, A. Carr, C. Brown, D. Prieto-Alhambra, S. Glyn-Jones. Surrogate markers of long-term outcome in primary total hip arthroplasty: A systematic review. Bone Joint Res 2016;5:206–214. DOI: 10.1302/2046-3758.56.2000568


Bone & Joint Research
Vol. 6, Issue 9 | Pages 530 - 534
1 Sep 2017
Krakow L Klockow A Roehner E Brodt S Eijer H Bossert J Matziolis G

Objectives

The determination of the volumetric polyethylene wear on explanted material requires complicated equipment, which is not available in many research institutions. Our aim in this study was to present and validate a method that only requires a set of polyetheretherketone balls and a laboratory balance to determine wear.

Methods

The insert to be measured was placed on a balance, and a ball of the appropriate diameter was inserted. The cavity remaining between the ball and insert caused by wear was filled with contrast medium and the weight of the contrast medium was recorded. The volume was calculated from the known density of the liquid. The precision, inter- and intraobserver reliability, were determined by four investigators on four days using nine inserts with specified wear (0.094 ml to 1.626 ml), and the intra-class correlation coefficient was calculated. The feasibility of using this method in routine clinical practice and the time required for measurement were tested on 84 explanted inserts by one investigator.


Bone & Joint Research
Vol. 6, Issue 5 | Pages 270 - 276
1 May 2017
Gosiewski JD Holsgrove TP Gill HS

Objectives

Fractures of the proximal femur are a common clinical problem, and a number of orthopaedic devices are available for the treatment of such fractures. The objective of this study was to assess the rotational stability, a common failure predictor, of three different rotational control design philosophies: a screw, a helical blade and a deployable crucifix.

Methods

Devices were compared in terms of the mechanical work (W) required to rotate the implant by 6° in a bone substitute material. The substitute material used was Sawbones polyurethane foam of three different densities (0.08 g/cm3, 0.16 g/cm3 and 0.24 g/cm3). Each torsion test comprised a steady ramp of 1°/minute up to an angular displacement of 10°.


Bone & Joint Research
Vol. 1, Issue 8 | Pages 180 - 191
1 Aug 2012
Stilling M Kold S de Raedt S Andersen NT Rahbek O Søballe K

Objectives

The accuracy and precision of two new methods of model-based radiostereometric analysis (RSA) were hypothesised to be superior to a plain radiograph method in the assessment of polyethylene (PE) wear.

Methods

A phantom device was constructed to simulate three-dimensional (3D) PE wear. Images were obtained consecutively for each simulated wear position for each modality. Three commercially available packages were evaluated: model-based RSA using laser-scanned cup models (MB-RSA), model-based RSA using computer-generated elementary geometrical shape models (EGS-RSA), and PolyWare. Precision (95% repeatability limits) and accuracy (Root Mean Square Errors) for two-dimensional (2D) and 3D wear measurements were assessed.