Evidence map›Paper›PMID 30373659›Full record

ArticleTrials2018

Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18-50 years) femoroacetabular impingement: a statistical analysis plan.

Nicole Simunovic, D Heels-Ansdell, L Thabane, O R Ayeni, FIRST Investigators

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01623843 (Femoroacetabular Impingement RandomiSed Controlled Trial), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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.

NCT01623843 nacompletednot on this map

Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST); Sub-study: Femoroacetabular Impingement RandomiSed Controlled Trial With an Embedded Prospective Cohort (FIRST-EPIC)

TypeinterventionalSponsorMcMaster UniversityRan2012 to 2020Enrolled220ConditionsFemoroacetabular ImpingementArmsArthroscopic Lavage, Arthroscopic Osteochondroplasty
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Arthroscopic surgery versus physiotherapy for femoroacetabular impingement: a meta-analysis study.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2020
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Femoroacetabular impingement: question-driven review of hip joint pathophysiology from asymptomatic skeletal deformity to end-stage osteoarthritis.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2019
    Review
  9. Review
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

5 authors at 2 institutions in 1 country.

Nicole SimunovicDepartment of Surgery, Division of Orthopaedic Surgery, McMaster University, 1200 Main St W, 4E15, Hamilton, ON, L8N 3Z5, Canada.
D Heels-AnsdellDepartment of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St W, 2C, Hamilton, ON, L8S 4K1, Canada.
L ThabaneDepartment of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St W, 2C, Hamilton, ON, L8S 4K1, Canada.
O R AyeniDepartment of Surgery, Division of Orthopaedic Surgery, McMaster University, 1200 Main St W, 4E15, Hamilton, ON, L8N 3Z5, Canada. ayenif@mcmaster.ca.
FIRST Investigators
Impact · CAMcMaster University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe research objectives of the Femoroacetabular Impingement Randomised controlled Trial (FIRST) are to assess whether surgical correction of the hip impingement morphology (arthroscopic osteochondroplasty) with or without labral repair, in adults aged 18-50 years diagnosed with non-arthritic femoroacetabular impingement (FAI), provides decreased pain and improved health-related quality of life at 12 months compared to arthroscopic lavage of the hip joint. This article describes the statistical analysis plan for the FIRST trial. METHODS/

designFIRST is an ongoing multi-centre, blinded randomised controlled trial of 220 patients who have been diagnosed with FAI and are optimized for surgical intervention. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of the results, adjustments for covariates, the primary and secondary outcomes and their respective analyses. In addition, we will present the planned sensitivity and subgroup analyses. DISCUSSION: Our rationale for FIRST is based upon (1) an epidemic of FAI surgery with resultant increased healthcare costs over that last decade, (2) worldwide disparity in perceptions about its utility, and (3) consensus that definitive evidence for or against surgical approaches is lacking.

trial registrationClinicalTrials.gov, NCT01623843 . Registered on 20 June 2012.

Indexed as

Quality of LifeAdolescentAdultArthroscopyCanadaData Interpretation, StatisticalFemaleFemoracetabular ImpingementHumansMaleMiddle AgedMulticenter Studies as TopicPain MeasurementRandomized Controlled Trials as TopicRecovery of FunctionTherapeutic IrrigationFemoroacetabular impingementLavageOsteochondroplastyRandomised controlled trialStatistical analysis plan

Identifiers

PMID30373659
PMCPMC6206648
OpenAlexW2899068709

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.