Evidence map›Paper›PMID 31651318›Full record

Trial reportBMC musculoskeletal disorders2019

No added value for Computer-Assisted surgery to improve femoral component positioning and Patient Reported Outcomes in Hip Resurfacing Arthroplasty; a multi-center randomized controlled trial.

M C Koper, M Reijman, E M van Es, J H Waarsing, H W J Koot, S B Keizer, I Jansen, F C van Biezen, J A N Verhaar, P K Bos

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC musculoskeletal disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 40% of its field
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.

NCT00391937 phase3completednot on this map

Efficacy of a New Resurfacing Hip Prosthesis. A Multicenter, Prospective, Randomized, Controlled Study

TypeinterventionalSponsorErasmus Medical CenterRan2006 to 2013Enrolled150ConditionsOsteoarthritis, HipArmsArticular Surface Replacement (ASR) hip prosthesis
NCT05393778 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Accuracy in aChieving Optimum reconstrUction: Measured- vs. Navigation- Techniques in Hip Arthroplasty

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2022 to 2024Enrolled100ConditionsOsteoarthritis, HipArmsMeasured Technique, Navigated Technique
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

M C KoperDepartment of Orthopedics, Erasmus University Medical Center, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands. maartenkoper@outlook.com.ORCID http://orcid.org/0000-0001-7573-332X
M ReijmanDepartment of Orthopedics, Erasmus University Medical Center, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
E M van EsDepartment of Orthopedics, Erasmus University Medical Center, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
J H WaarsingDepartment of Orthopedics, Erasmus University Medical Center, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
H W J KootDepartment of Orthopedics, Maxima Medical Center, Eindhoven, The Netherlands.
S B KeizerDepartment of Orthopedics, Medical Center Haaglanden, Den Haag, The Netherlands.
I JansenDepartment of Orthopedics, Admiraal de Ruyter Hospital, Goes, The Netherlands.
F C van BiezenDepartment of Orthopedics, Erasmus University Medical Center, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
J A N VerhaarDepartment of Orthopedics, Erasmus University Medical Center, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
P K BosDepartment of Orthopedics, Erasmus University Medical Center, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
Erasmus MC · NLAdmiraal De Ruyter Ziekenhuis · NLMedisch Centrum Haaglanden · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundComputer Assisted Surgery (CAS) has proven to improve the accuracy in several orthopedic procedures. Therefore we used this technique to evaluate femoral component positioning in Hip Resurfacing Arthroplasty (HRA). The aim of this study was to evaluate imageless CAS compared to manually implanted femoral components and subsequently evaluates Patient Related Outcome Measures (PROMs). We hypothesized that the use of CAS optimizes the position of the femoral component and improves PROMs.

methodsThis is a multicenter, single-blinded, randomized, controlled trial of two groups. In the CAS group guiding of the femoral component was done with imageless navigation. In the Conventional (control) group the femoral component was placed manually according to the preplanned position. The primary outcome measure consists of a maximum of 3 degrees difference between the postoperative Stem Shaft Angle (SSA) and preplanned SSA. Secondary outcome measures consist of the Hip disability and Osteoarthritis Outcome Scale (HOOS), the Harris Hip Score (HHS) and Visual Analogue Scale (VAS) pain score.

resultsA total of 122 patients were randomized, 61 in the CAS group and 61 in the conventional group. There was no significant differences in accuracy of femoral implant position. The mean difference between the postoperative- and preplanned SSA was - 2.26 and - 1.75 degrees (more varus) respectively in the CAS and Conventional group. After surgery both groups show significant improvement in all PROMs compared to the baseline measurements, with no significant differences between the groups.

conclusionOur cohort indicates no benefit for the use of CAS in accuracy of placement of the femoral component in HRA compared to manual implantation. There are no clinical differences in PROMs after 1 year follow up. This study showed no added value and no justification for the use of CAS in femoral component positioning in HRA.

trial registrationThis trial is registered at ClinicalTrails.gov ( https://clinicaltrials.gov/ ) on the 25th of October 2006: NCT00391937. LEVEL OF INCIDENCE: Level IIb, multicenter randomized controlled trial.

Indexed as

Arthroplasty, Replacement, HipHip ProsthesisOsteoarthritis, HipPatient Reported Outcome MeasuresSurgery, Computer-AssistedAdultFemaleFemurFollow-Up StudiesHumansMaleMiddle AgedPostoperative PeriodRadiographySingle-Blind Method

Identifiers

PMID31651318
PMCPMC6814023
OpenAlexW2982194355

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.