Evidence map›Paper›PMID 27121872›Full record

ArticleClinical orthopaedics and related research2016

Are Females at Greater Risk for Revision Surgery After Hip Resurfacing Arthroplasty With the Articular Surface Replacement Prosthesis?

Gabrielle S Donahue, Viktor Lindgren, Vincent P Galea, Rami Madanat, Orhun Muratoglu, Henrik Malchau

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter Study
In one paragraph

Article 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 NCT01611233 (Clinical Follow-up of ASR Patients Post-Recall), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT01611233 unknown statusnot on this map

Clinical Follow-up of ASR Patients Post-Recall

TypeobservationalSponsorMassachusetts General HospitalRan2012 to 2022Enrolled1,950ConditionsOsteoarthritis
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 1 institution in 2 countries.

Gabrielle S DonahueHarris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, MA, USA.
Viktor LindgrenHarris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, MA, USA.
Vincent P GaleaHarris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, MA, USA.
Rami MadanatHarris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, MA, USA.
Orhun MuratogluMassachusetts General Hospital, 55 Fruit Street, GRJ 1231, Boston, MA, 02114, USA.
Henrik MalchauMassachusetts General Hospital, 55 Fruit Street, GRJ 1231, Boston, MA, 02114, USA. hmalchau@mgh.harvard.edu.
Massachusetts General Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFemale patients undergoing hip resurfacing arthroplasties may be at greater risk of revision surgery than males, but it is unclear whether this is related to sex or other factors. We focused our analysis on data from a prospective multicenter cohort study monitoring the ASR(TM) hip resurfacing arthroplasty prosthesis on the potential association of sex on patient-reported outcome measures (PROMs), metal ion levels, revision surgery, and presence of adverse local tissue reaction. As thousands of patients with the ASR(TM) prosthesis are still undergoing followup it is critical to optimize the protocol for monitoring these patients. QUESTIONS/PURPOSES: We wished (1) to assess the associations between sex and implant survival, and adverse local tissue reaction; and (2) to report the differences between sexes in metal ion levels and patient-reported outcome measures.

methodsOne thousand two hundred fifty-two patients (1390 hips) who underwent hip resurfacing arthroplasty with implantation of the ASR(TM) prosthesis from April 2003 to July 2010 were eligible for enrollment in a multicenter followup study of the ASR(TM) Hip Resurfacing System after the voluntary recall of this device was initiated by DePuy in 2010. Nine hundred seventy patients (1098 hips) were enrolled at a mean of 7 years after surgery, with a mean followup of 2 years (range, 1-3.5 years). Nine hundred fifty-eight patients (1084 hips) met the inclusion criteria: ability to provide informed consent, complete PROMs, and continued routine followup. A subset of patients (150 patients, 171 hips), who all were from one center, with annual metal artifact reduction sequence MRI were analyzed. Ninety-three percent of patients from this center had routine MRI performed. The EuroQoL (EQ-5D), Harris hip score (HHS), University of California Los Angeles (UCLA) activity score, VAS pain, radiographs, patient and surgery details, and blood cobalt and chromium levels were obtained. Cox regression analysis was conducted to identify factors associated with implant survival, using any revision as the end point, and presence of adverse local tissue reaction.

resultsIn patients who had unilateral surgery, the only variable found to be associated with revision surgery was HHS (hazard ratio [HR], 0.96; 95% CI, 0.94-0.97; p < 0.001). In patients who had bilateral surgery, only HHS (HR, 0.93; 95% CI, 0.90-0.97; p < 0.001) and cobalt level (HR, 1.02; 95% CI, 1.01-1.03; p < 0.001) were associated with risk for revision. In patients with metal artifact reduction sequence MRI, the only variable found to be associated with presence of adverse local tissue reaction was cobalt level (HR, 1.06; 95% CI, 1.02-1.10; p = 0.001). Cobalt and chromium concentrations were greater in female patients than in male patients (cobalt, median 1.89 versus median 1.12 parts per billion [ppb], p < 0.001; chromium, median 2.03 versus median 1.17 ppb, p < 0.001). Slight differences were observed between males and females in HHS (males median 96 versus females median 94, p < 0.001) and UCLA scores (median 8 versus median 6, p < 0.001); however, there was no difference between sexes for VAS pain (median 0.5 versus median 0.5, p = 0.405). Differences were identified between males and females in the distribution of EQ-5D scores, yet the medians were the same (median 1.0 versus median 1.0, p < 0.001).

conclusionsMale and female patients who had hip resurfacing arthroplasty with implantation of the ASR(TM) prosthesis should be followed with equal vigilance as both are at similar risk of revision surgery and adverse local tissue reaction. Metal ion levels and HHS should be obtained at followup to monitor for risk of revision and as a screening tool for MRI. Further research is necessary to evaluate if these relationships persist in patients with other metal-on-metal prostheses. LEVEL OF EVIDENCE: Level II, therapeutic study.

Indexed as

Hip ProsthesisProsthesis FailureReoperationAdolescentAdultAgedAged, 80 and overArthroplasty, Replacement, HipAustraliaBostonChi-Square DistributionEuropeFemaleHip JointHumansKaplan-Meier EstimateMetals

Identifiers

PMID27121872
PMCPMC5014806
OpenAlexW2344435555

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.