Evidence map›Paper›PMID 26618662›Full record

Trial reportJournal of orthopaedic trauma2016

Reaming Does Not Affect Functional Outcomes After Open and Closed Tibial Shaft Fractures: The Results of a Randomized Controlled Trial.

Carol A Lin, Marc Swiontkowski, Mohit Bhandari, Stephen D Walter, Emil H Schemitsch, David Sanders, Paul Tornetta

Erratum issued Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of orthopaedic trauma, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03196258 (Cognitive Behavioural Therapy to Improve Outcomes of High Risk Patients Following Internal Fixation of Extremity Fractures), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–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.

NCT03196258 naterminatednot on this mapstarted 2018, after this paper: background citation

Cognitive Behavioural Therapy to Improve Outcomes of High Risk Patients Following Internal Fixation of Extremity Fractures: A Randomized Controlled Trial (SPOC-CBT)

TypeinterventionalSponsorMcMaster UniversityRan2018 to 2019Enrolled8ConditionsPain, Postoperative, Fractures, Closed, Fractures, OpenArmsCognitive behavioural therapy
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Effect of Vitamin DJBMR plus · 2023
    Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Risk factors for delayed return to work following tibial shaft fracture surgery.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2024
    Article
  9. Article
  10. Incidence and Risk Factors of Heterotopic Ossification in the Knee After Reamed Tibial Nailing.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2024
    Article
  11. Article
  12. Article
  13. Rethinking the Coronal Anatomic Axis of the Distal Tibia for Intramedullary Nail Placement: A Cadaveric Study.HSS journal : the musculoskeletal journal of Hospital for Special Surgery · 2022
    Article
  14. Radiographic and clinical outcomes of distal tibia fractures (3-12 cm proximal to the plafond): Comparison of two intramedullary nailing.Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES · 2022
    Article
  15. Review
  16. Article
  17. Article
  18. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Carol A Lin*Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Orthopedic Center, Los Angeles, CA; †Department of Orthopedic Surgery, Minneapolis, University of Minnesota, MN; ‡SPRINT Methods Center, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; §Department of Clinical Epidemiology and Biostatistics, Health Sciences Centre, Hamilton, ON, Canada; ‖Department of Orthopaedic Surgery, University of Toronto St. Michael's Hospital, Toronto, ON, Canada; ¶Department of Orthopedic Surgery, University of Western Ontario London Health Sciences Centre, London, ON, Canada; and **Department of Orthopedic Surgery, Boston Medical Center, Boston, MA.
Marc Swiontkowski
Mohit Bhandari
Stephen D Walter
Emil H Schemitsch
David Sanders
Paul Tornetta

Funding

SPRINT- Randomized Trial of Tibial Fracture FixationR01AR048529 · NIAMS · UNIVERSITY OF MINNESOTA TWIN CITIES · PI SWIONTKOWSKI, MARC F · 2002 to 2006
$1.1M
Canadian Institutes of Health Research MCT-38140NIAMS NIH HHS R01 AR048529NIAMS NIH HHS R01 AR48529
6 · The paper itself

Abstract

objectivesWe sought to determine the effect of reaming on 1-year 36-item short-form general health survey (SF-36) and short musculoskeletal function assessment (SMFA) scores from the Study to Prospectively Evaluate Reamed Intramedullary Nails in patients with Tibial Fractures.

designProspective randomized controlled trial.1319 patients were randomized to reamed or unreamed nails. Fractures were categorized as open or closed.

settingTwenty-nine academic and community health centers across the US, Canada, and the Netherlands. PATIENTS/

participantsOne thousand three hundred and nineteen skeletally mature patients with closed and open diaphyseal tibia fractures.

interventionReamed versus unreamed tibial nails. MAIN OUTCOME MEASUREMENTS: SF-36 and the SMFA. Outcomes were obtained during the initial hospitalization to reflect preinjury status, and again at the 2-week, 3-month, 6-month, and 1-year follow-up. Repeated measures analyses were performed with P < 0.05 considered significant.

resultsThere were no differences between the reamed and unreamed groups at 12 months for either the SF-36 physical component score [42.9 vs. 43.4, P = 0.54, 95% Confidence Interval for the difference (CI) -2.1 to 1.1] or the SMFA dysfunction index (18.0 vs. 17.6, P = 0.79. 95% CI, -2.2 to 2.9). At one year, functional outcomes were significantly below baseline for the SF-36 physical componentf score, SMFA dysfunction index, and SMFA bothersome index (P < 0.001). Time and fracture type were significantly associated with functional outcome.

conclusionsReaming does not affect functional outcomes after intramedullary nailing for tibial shaft fractures. Patients with open fractures have worse functional outcomes than those with a closed injury. Patients do not reach their baseline function by 1 year after surgery. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Indexed as

AdultCanadaClosed Fracture ReductionFemaleFracture Fixation, IntramedullaryFracture HealingFractures, ClosedFractures, OpenHumansMaleNetherlandsOpen Fracture ReductionOsteotomyPrevalenceQuality of LifeRecovery of Function

Identifiers

PMID26618662
PMCPMC4761270

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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.