Evidence map›Paper›PMID 35097143›Full record

ArticleOrthopaedic journal of sports medicine2022

Design Features and Rationale of the BEAR-MOON (Bridge-Enhanced ACL Restoration Multicenter Orthopaedic Outcomes Network) Randomized Clinical Trial.

BEAR-MOON Design Group, Kurt P Spindler, Peter B Imrey, Sercan Yalcin, Gerald J Beck, Gary Calbrese, Charles L Cox, Paul D Fadale, Lutul Farrow, Robert Fitch and 15 more

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

Article in Orthopaedic journal of sports medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03776162 (BEAR - MOON), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03776162 naactive not recruitingnot on this map

BEAR - MOON: A Two Arm Non-Inferiority Randomized Clinical Trial Comparing ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction

TypeinterventionalSponsorThe Cleveland ClinicRan2021 to 2027Enrolled150ConditionsAnterior Cruciate Ligament TearArmsACL Reconstruction (Bone Patellar Tendon Bone Graft), Bridge Enhanced ACL Restoration (BEAR)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

25 authors.

BEAR-MOON Design Group
Kurt P SpindlerBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Peter B ImreyBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Sercan YalcinBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Gerald J BeckBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Gary CalbreseBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Charles L CoxBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Paul D FadaleBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Lutul FarrowBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Robert FitchBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
David FlaniganBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Braden C FlemingBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Michael J HulstynBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Morgan H JonesBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Christopher KaedingBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Jeffrey N KatzBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Peter KrizBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Robert MagnussenBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Ellen McErleanBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Carrie MelgaardBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Brett D OwensBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Paul SaluanBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Greg StrnadBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Carl S WinalskiBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.
Rick WrightBEAR-MOON Design Group: All authors are listed in the Authors section at the end of this article.

Funding

BEAR-MOON: A Two Arm Noninferiority Blinded Randomized Clinical Trial Comparing ACL Repair with BEAR Device vs. Standard of Care Autograft Patellar Tendon ACL ReconstructionR01AR074131 · NIAMS · CLEVELAND CLINIC LERNER COM-CWRU · PI SPINDLER, KURT PAUL · 2018 to 2024
$6.0M
NIAMS NIH HHS R01 AR074131
6 · The paper itself

Abstract

backgroundBEAR (bridge-enhanced anterior cruciate ligament [ACL] restoration), a paradigm-shifting technology to heal midsubstance ACL tears, has been demonstrated to be effective in a single-center 2:1 randomized controlled trial (RCT) versus hamstring ACL reconstruction. Widespread dissemination of BEAR into clinical practice should also be informed by a multicenter RCT to demonstrate exportability and compare efficacy with bone--patellar tendon-bone (BPTB) ACL reconstruction, another clinically standard treatment. PURPOSE: To present the design and initial preparation of a multicenter RCT of BEAR versus BPTB ACL reconstruction (the BEAR: Multicenter Orthopaedic Outcomes Network [BEAR-MOON] trial). Design and analytic issues in planning the complex BEAR-MOON trial, involving the US National Institute of Arthritis and Musculoskeletal and Skin Diseases, the US Food and Drug Administration, the BEAR implant manufacturer, a data and safety monitoring board, and institutional review boards, can usefully inform both clinicians on the trial's strengths and limitations and future investigators on planning of complex orthopaedic studies. STUDY

designClinical trial.

methodsWe describe the distinctive clinical, methodological, and operational challenges of comparing the innovative BEAR procedure with the well-established BPTB operation, and we outline the clinical motivation, experimental setting, study design, surgical challenges, rehabilitation, outcome measures, and planned analysis of the BEAR-MOON trial.

resultsBEAR-MOON is a 6-center, 12-surgeon, 200-patient randomized, partially blinded, noninferiority RCT comparing BEAR with BPTB ACL reconstruction for treating first-time midsubstance ACL tears. Noninferiority of BEAR relative to BPTB will be claimed if the total score on the International Knee Documentation Committee (IKDC) subjective knee evaluation form and the knee arthrometer 30-lb (13.61-kg) side-to-side laxity difference are both within respective margins of 16 points for the IKDC and 2.5 mm for knee laxity.

conclusionMajor issues include patient selection, need for intraoperative randomization and treatment-specific postoperative physical therapy regimens (because of fundamental differences in surgical technique, initial stability construct, and healing), and choice of noninferiority margins for short-term efficacy outcomes of a novel intervention with evident short-term advantages and theoretical, but unverified, long-term benefits on other dimensions.

Indexed as

ACL reconstructionACL repairIKDCinstrumented knee laxityRCT

Identifiers

PMID35097143
PMCPMC8793429

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.