Clinical Evidence Current Studies
Current studies in 2020
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AO Trauma
Short title Project title
Principal Coordinating Investigator
Clin.Trial.gov
NCT numberCurrent Phase
CPP Bone Infection Registry Implementation of a registry on bone infection to improve patient outcomes and research efforts (CPP Bone Infection Registry)
Stephen Kates
NCT01677000
Analysis
Multicenter prospective registry for periprosthetic fractures after hip or knee arthroplasty (PPFx Registry)
Karl Stoffel
NCT03378557
Monitoring
A prospective multicenter cohort study to evaluate the benefit of the geriatric fracture center concept (GFC)
Michael Blauth
NCT02297581
Analysis
A prospective multicenter cohort study to evaluate the effect of early mobilization of patients after hip fracture fixation on functional outcomes in the Chinese population (MobiChina)
Frankie Leung
NCT02296086
Analysis
MobiChina survey
Frankie Leung
n/a
Monitoring
Clinical Priority Program (CPP III pre-project prox humerus)
Laurent Audigé
n/a
Analysis
Clinical Priority Program (CPP) Patient Outcome Project I:
Translation, Cultural Adaptation and Cognitive Debriefing of Extension Items of PROMIS Physical Function item bank V2.0 in German and SpanishMarilyn Heng, Claudia Hartmann
n/a
Planning
Clinical Priority Program (CPP Patient Outcome Project II:
GO FIT FAST - Gait Observation for Fully Individualized Treatment and Aftercare following Surgery and TraumaTim Pohlemann, Benedikt Braun
NCT04113044 Planning
Clinical Priority Program (CPP) Patient Outcome Project III:
Development of interpretation guidance for clinicians to better understand meaning of PROMIS scoresPrakash Jayakumar, Marilyn Heng, Stephen Gwilym
NCT04113044
Planning
Clinical Priority Program (CPP) Patient Outcome Project IV:
Linking of PROMIS Physical Function to Legacy Measures in an Orthopaedic Patient PopulationMarilyn Heng (center 1),
Tim Pohlemann, Benedikt Braun (Center 2), Prakash Jayakumar (Center 3)NCT04113044
Planning
Clinical Priority Program (CPP) Patient Outcome Project V:
Norm Data - Collection of international Age-based Norm Data for interpretation of scores obtained from the newly extended PROMIS® Physical Function item bank version 2.0Matthias Rose
n/a
Planning
Clinical Priority Program (CPP) Patient Outcome Project VI:
Standard setting to develop PROMIS score severity threshold categoriesMarilyn Heng
n/a
Planning
AO multicenter intervention trial to evaluate the impact of a bundle of measures for the prevention of surgical site infection in fracture patients (AOPOSSI)
Stephen L. Kates
NCT03380273
Planning
(LAMOS) Latin America hip fracture mortality study
William Belangero
NCT01650064
Publication
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AO Spine
Project title (short title)
Principal Coordinating
InvestigatorClin.Trial.gov
NCT numberCurrent Phase
The epidemiology, process and outcomes of spine oncology (EPOSO)
Charles Fisher
n/a
Monitoring
Spinal deformity intraoperative monitoring: understanding and managing intraoperative neuromonitoring changes during spinal deformity surgery (SDIM)
Stephen Lewis
NCT03880292
Monitoring
Prospective evaluation of elderly deformity surgery (PEEDS)
Stephen Lewis
NCT02035280
Monitoring
Metastatic tumor research and outcomes network: a multicenter prospective registry for the management of metastatic spine tumors (MTRON)
Charles Fisher
NCT02830451
Monitoring
Primary tumor research and outcomes network: A multicenter prospective registry for the management of primary tumors of the spine (PTRON)
Charles Fisher
NCT02790983
Monitoring
Evaluation of neurologic complications associated with surgical correction of adult spinal deformity (Scoli-RISK-1)
Lawrence Lenke
NCT01305343
Publication
Evaluation of neurologic complications associated with surgical correction of adult spinal deformity: 5-year follow-up extension (Scoli-RISK-1-extension)
Lawrence Lenke
NCT02949245
Analysis
Spine registry to collect outcome measures related to the disease status of patients with dpine disorders (DegenPRO)
Tim Yoon
NCT02802033
Monitoring
Thoracolumbar burst fractures (AOSpine A3, A4) in neurologically intact patients: an observational, multicenter cohort study comparing surgical versus non-surgical treatment (Spine_TL-A3-A4)
Marcel Dvorak
NCT02827214
Monitoring
Prognostic factors and therapeutic effects of surgical treatment for traumatic spinal column iInjury with spinal cord injury (SCI POEM)
Allard Hosman
NCT01674764
Analysis
C-Classification
Alex Vaccaro
n/a
Analysis
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AO CMF
Project title (short title)
Principal Coordinating Investigator
Clin.Trial.gov NCT number
Current Phase
An international, multicenter, prospective registry to collect data of treatment patterns of patients with Medication-Related OsteoNecrosis of the Jaw (MRONJ) and their outcome (MRONJ registry)
Risto Kontion (University of Helsinki) and Sven Otto (Ludwig-Maximilian University, Munich)
NCT02932501
Monitoring
International, multicenter, prospective registry to collect data of treatment patterns in patients with bilateral condylar fracture (BCFx) of the mandible (BCFx registry)
Risto Kontio (University of Helsinki) and Edward Ellis 3rd (University of Texas Health Science Center at San Antonio)
NCT02884765
Monitoring
A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures (DMFx)
Risto Kontio and Edward Ellis 3rd
NCT02341443
Publication
Orbita 3 - Additional publication
n/a
Publication
International, multicenter, prospective registry to collect data on orbital fractures (OFx), their treatment and outcome
Eppo B. Wolvius
NCT03887988
Monitoring
International, multicenter, prospective registry to collect data in patients > 60 years suffering from mandibular fractures (MFx 60+)
Risto Kontio
NCT03849898
Monitoring
International, multicenter, prospective registry to collect data of patients treated with alloplastic temporomandibular joint (TMJ) replacements
Andreas Thor
NCT03991728
Monitoring
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AO Technical Commission
Project title (short title)
Principal Coordinating Investigator
Clin.Trial.gov NCT number
Current Phase
Evaluation of a growth guiding construct vs. standard dual growing rods and VEPTR for the treatment of early onset scoliosis patients: A prospective multi-center cohort study with a matched historical control. (TROLLEY)
Jean Ouellet, MD, FRCSC
NCT01672749
Monitoring
A focused registry on the conservative treatment of osteoarthritis of the knee (FR Tomofix)
Takeshi Sawaguchi
NCT02077647
Publication OpenGo Sensor Insole in open wedge HTO (Moticon - HTO)
Stefan Döbele, Steffen Schröter
Monitoring
A prospective study to investigate postoperative real life weight bearing measured in patients treated with a Trochanter Fixation Nail Advanced (TFNA weight bearing)
Michael Blauth, Karl Stoffel
Monitoring
A prospective multicenter observational registry for children up to 16 years of age with femur shaft fractures (PedFemFx)
Peter Schmittenbecher, Unni Narayanan
Monitoring
A prospective case series study to monitor healing progression and real life weight bearing after tibial fracture using smart biofeedback systems (SmartFix II - Moticon)
Stefan Döbele
Monitoring
A focused registry on the Femoral Neck System (FNS) in patients with femoral neck fractures (FR FNS)
Karl Stoffel
Monitoring
A randomized multicenter study comparing the effectiveness of hemi versus total shoulder arthroplasty in patients with a degenerative joint disease (EPOCA)
Norbert Suedkamp
Monitoring
Multicenter prospective registry for periprosthetic fractures after hip or knee arthroplasty (PPFx Registry)
Karl Stoffel
Monitoring
Prospective multicenter registry for use of the MAXFRAMETM Multiaxial Correction System (MAXFRAME)
Teddy Slongo
Planning
Locking plates for distal femur fractures – a multicenter case review
A retrospective radiological analysis of the mechanical performance of different locking plates in distal femoral fractures (VA-LCP Case review)Mark Lee
n/a
Monitoring
An international, multicenter, prospective registry to investigate treatment options and their outcomes on Long Bones Defects (LoBoDeRe)
Christoph Pape
Planning
Fracture-Related Outcome Study for operatively treated Tibia shaft fractures (FROST)
Willem-Jan Metsemakers
Monitoring
Multicenter registry on indications, safety and clinical outcome of internal univector and curvilinear distraction devices in the treatment of congenital and acquired deformities of the craniomaxillofacial (CMF) skeleton (CMF distractor).
Richard A. Hopper
TBD Idea International, multicenter, prospective registry to collect data on treatment, outcome, and complications subsequent to reconstruction of acquired segmental mandibular defects in oral squamous cell carcinoma patients - SMDR (Segmental Mandibular Defect Reconstruction) registry
Rüdiger M. Zimmerer
NCT04098146
Planning An International, Multicenter, Focused Registry to collect clinical data on the MatrixWAVE Mandibulo-Maxillary Fixation System (MatrixWAVE)
Carl-Peter Cornelius
NCT03405389
Monitoring
International, multicenter, prospective registry on
Patient-Specific Orthognathic Solutions (PSOS)
Daniel Buchbinder
TBD
Idea
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AO Education Institute
Project title (short title)
Principal Coordinating Investigator
Clin.Trial.gov NCT number
Current Phase
Development of performance metrics for cephalomedullary nailing for unstable pertrochanteric fractures- phase 1 (Immpact)
Anthony Gallagher
TBD
Montoring
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AO Development Incubator
Project title (short title)
Principal Coordinating Investigator
Clin.Trial.gov NCT number
Current Phase
Retrospective data collection in patients treated with immobilization of the metacarpals and/or phalanges of the hand with external fixation with K-wires and the fixation block "K-Blocks" (K-Blocks)
Karl Heinz Bürger
TBD
Planning
Prospective case series to analyze safety data in femoral and proximal tibial fracture patients treated with a locking compression plate with an attached investigational Fracture Monitor (Fracture Monitor-Femur/Proximal Tibia)
Bendikt Braun
TBD
Planning
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Collaboration with the AO Research Institute Davos (ARI)
Project title (short title)
Principal Coordinating Investigator
Clin.Trial.gov NCT number
Current Phase
A prospective case series study to monitor healing progression and real life wieght bearing after tibial fracture using smart biofeedback systems (Moticon SmartFix II)
Stefan Döbele
NCT03166267
Monitoring
Next generation SmartFix-integration with implants (SmartPlate)
n/a
n/a
Idea
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Clinical Science
Clinical evidence generated through AO clinical studies can be accessed in the form of journal articles, presentations at scientific meetings, final study reports, guidelines, classifications, and/or news on the AO website.