Evidence map›Paper›PMID 27334320›Full record

Trial reportClinical orthopaedics and related research2016

Is Model-based Radiostereometric Analysis Suitable for Clinical Trials of a Cementless Tapered Wedge Femoral Stem?

Sanaz Nazari-Farsani, Sami Finnilä, Niko Moritz, Kimmo Mattila, Jessica J Alm, Hannu T Aro

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical orthopaedics and related research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01926158 (Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01926158 phase4completednot on this map

Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women: a Randomized, Double-blind, Placebo-controlled Study

TypeinterventionalSponsorTurku University HospitalRan2013 to 2017Enrolled65ConditionsHip OsteoarthritisArmsDenosumb, Placebo (for denosumab)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Low dose CT-based spatial analysis (CTSA) to measure implant migration after ceramic hip resurfacing arthroplasty (HRA): A phantom study.Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine · 2023
    Article
  4. Article
  5. RSA of the Symax hip stem.Acta orthopaedica · 2020
    Article
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Sanaz Nazari-FarsaniOrthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, University of Turku and Turku University Hospital, T-hospital, PL 52, 20521, Turku, Finland.
Sami FinniläOrthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, University of Turku and Turku University Hospital, T-hospital, PL 52, 20521, Turku, Finland.
Niko MoritzOrthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, University of Turku and Turku University Hospital, T-hospital, PL 52, 20521, Turku, Finland.
Kimmo MattilaMedical Imaging Centre of Southwest Finland, Turku University Hospital, Kiinamyllynkatu 4-8, 20520, Turku, Finland.
Jessica J AlmOrthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, University of Turku and Turku University Hospital, T-hospital, PL 52, 20521, Turku, Finland.
Hannu T AroOrthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, University of Turku and Turku University Hospital, T-hospital, PL 52, 20521, Turku, Finland. hannu.aro@utu.fi.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn clinical trials of THA, model-based radiostereometric analysis (RSA) techniques may be less precise than conventional marker-based RSA for measurement of femoral stem rotation. We verified the accuracy and clinical precision of RSA based on computer-aided design models of a cementless tapered wedge femoral stem. QUESTIONS: We asked: (1) Is the accuracy of model-based RSA comparable to that of marker-based RSA? (2) What is the clinical precision of model-based RSA?

methodsModel-based RSA was performed using combined three-dimensional computer-aided design models of the stem and head provided by the implant manufacturer. The accuracy of model-based RSA was compared with that of marker-based RSA in a phantom model using micromanipulators for controlled translation in three axes (x, y, z) and rotation around the y axis. The clinical precision of model-based RSA was evaluated by double examinations of patients who had arthroplasties (n = 24) in an ongoing trial. The clinical precision was defined as being at an acceptable level if the number of patients needed for a randomized trial would not differ from a trial done with conventional marker-based RSA (15-25 patients per group).

resultsThe accuracy of model-based RSA was 0.03 mm for subsidence (translation along the y axis) (95% CI for the difference between RSA measurements and actual displacement measured with micrometers, -0.03-0.00) and 0.39° for rotation around the y axis (95% CI, -0.41 to -0.06). The accuracy of marker-based RSA was 0.06 mm for subsidence (95% CI, -0.04-0.01; p = 0.728 compared with model-based RSA) and 0.18° for the y axis rotation (95% CI, -0.23 to -0.07; p = 0.358). The clinical precision of model-based RSA was 0.14 mm for subsidence (95% CI for the difference between double examinations, -0.02-0.04) and 0.79° for the y axis rotation (95% CI, -0.16-0.18).

conclusionsThe accuracy of model-based RSA for measurement of the y axis rotation was not quite as high as that of marker-based RSA, but its clinical precision is at an acceptable level. CLINICAL RELEVANCE: Model-based RSA may be suitable for clinical trials of cementless tapered wedge femoral stem designs.

Indexed as

Hip ProsthesisModels, AnatomicRadiostereometric AnalysisResearch DesignAgedArthroplasty, Replacement, HipBiomechanical PhenomenaComputer SimulationFemaleFemurHip JointHumansImaging, Three-DimensionalMaleMiddle AgedPhantoms, Imaging

Identifiers

PMID27334320
PMCPMC5014820

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.