Clinical Evidence Completed Studies

AO Trauma

Short title	Project title	Principal Coordinating Investigator	Clin.Trial.gov NCT number
FFOB Hum	The influence of local bone status on complications after surgical treatment of proximal humerus fractures	Franz Kralinger, MD	NCT01143675
NonRandHum	Comparison of conservative versus operative treatment of humerus shaft fractures. Prospective Cohort Study		NCT00205972
PH Cons	Documentation of the results of conservative treatment of proximal humeral fractures
FFOB Rad	The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures	Daniel A Rikli, PD	NCT01144208
CEA Chile	Cost effectiveness analysis of scaphoid fractures in Chile
Scaphold	Operative Versus Conservative Treatment of Scaphoid Fractures	Markus Schaedel-Hoepfner, Prof. MD	NCT00205985
LAMOS	Latin America Hip Fracture Mortality Study	Wiliam Belangero, Dr. med	NCT01650064
SI Screw	Accuracy of Navigation in Placement of Accuracy of Navigation in Placement of Sacroiliac Screw	Ulrich C. Stöckle, Prof. MD	NCT00955565
LFN	Treatment of femoral fractures with the Expert™ Lateral Femoral Nail
LISS-DF	Minimal invasive Frakturstabilisierung von distalen Femurfrakturen mit dem LIS-System: Eine prospektive Multizenterstudie
HTO Navi	Prospective Study comparing the deviation from the leg-axis in navigated vs. non-navigated open-wedge high tibial osteotomies, receiving TomoFix®
TEFTOM	The role of patient expectations in traumatic orthopedic outcomes: the development of the trauma expectation factor trauma outcome measure	Michael Suk, Professor	NCT01126398
UTN Protect	Randomized controlled trial to evaluate the operative stabilization of closed and open diaphyseal fractures of the tibia using gentamicin-coated titanium nails (UTN/Expert TN + antibiotic coating®)
MOXFQ	TMT Fusion Plate vs. Two Crossed Screws (TMT)	Ian Winson, MB ChB, FRCS	NCT02096146
TEFTOM	The role of patient expectations in traumatic orthopedic outcomes (TEFTOM Eurasia) TEFTOM: The trauma expectation factor trauma outcomes measure	Reto Babst	NCT01134354
CPP Bone Infection Registry	Implementation of a registry on bone infection to improve patient outcomes and research efforts	Stephen Kates	NCT01677000
GFC	A prospective multicenter cohort study to evaluate the benefit of the geriatric fracture center concept	Michael Blauth	NCT02297581
MobiChina	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	Frankie Leung	NCT02296086
MobiChina	MobiChina survey	Frankie Leung	n/a
CPP III pre-project	Clinical Priority Program (CPP III pre-project prox humerus)	Laurent Audigé	n/a
CPP Patient Outcome Project V	Clinical Priority Program 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 2.0	Matthias Rose	n/a
CPP Patient Outcome Project VI	Clinical Priority Program Patient Outcome Project VI: Standard setting to develop PROMIS score severity threshold categories	Matthias Rose	n/a

AO Spine

Short title	Project title	Principal Coordinating Investigator	Clin.Trial.gov NCT number
CSM-I	An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy. International Multicenter Study	Michael Fehlings, MD, PhD	NCT00565734
CSM	An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy. Retrospective Study	Michael Fehlings, MD, PhD	NCT00285337
GOF	Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly	Alexander R Vaccaro, MD	NCT00266929
ScoliRisk 1	Neurologic Complications in Spinal Deformity Surgery	Lawrence Lenke, MD	NCT01305343
PAM	Posterior ligament complex assessment without magnetic resonance image in thoracolumbar fractures (T11-L2): A diagnostic test study to analyze sensitivity and specificity (PAM) .	Shanmuganathan Rajasekaran	NCT02950532
	Systematic literature research and review on biomaterials (allograft including DMB) used in cervical and lumbar fusion.	Jim Youssef; Hans Jörg Meisel	n/a
Scoli-RISK-1	Evaluation of neurologic complications associated with surgical correction of adult spinal deformity	Lawrence Lenke	NCT01305343
Scoli-RISK-1-extension	Evaluation of neurologic complications associated with surgical correction of adult spinal deformity: 5-year follow-up extension	Lawrence Lenke	NCT02949245
	C-Classification	Alexander R Vaccaro, MD	n/a

AO CMF

Short title	Project title	Principal Coordinating Investigator	Clin.Trial.gov NCT number
Orbita1	Evaluation of orbital volume differences
Orbita 3	Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants (Orbita 3)	Niels Gellrich	NCT01121159
DMFx	A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures	Risto Kontio and Edward Ellis 3rd	NCT02341443

AO Technical Commission

Short title	Project title	Principal Coordinating Investigator	Clin.Trial.gov NCT number
	Comparison of open surgery versus endoscopic approach in condylar neck fractures - functional outcome, cosmetic outcome, patient satisfaction (CMF Condylar Neck - nonrandomized)	Prof Dr Rainer Schmelzeisen	NCT00206011
PHILOS+	A Multicenter Randomized Controlled Trial to Investigate the Treatment Outcome of PHILOS Screw Augmentation Compared to PHILOS Without Augmentation in Older Adult Patients With Proximal Humerus Fractures	Franz Kralinger	NCT01847508
LCP DR 2.4mm	Surgical Plate Osteosynthesis of Distal Radius Fractures: Prospective study of the Locking Compression Plate (LCP DR 2.4mm)
LCP DR 3.5mm	Surgical Plate Osteosynthesis of Distal Radius Fractures: Prospective study of the Locking Compression Plate (LCP DR 3.5mm)
LCP DR Cons	Conservative treatment with or without reduction of distal radius fractures
LCP DR Retro	Distal radius fracture treatment. A retrospective study
LCP-FU Series	Evaluation of the safety of the LCP design on the outcome of fracture treatment
VA LCP DR	2.4 mm Variable Angle LCP Two-Column Volar Distal Radius	Jesse B Jupiter, MD Andreas Schierz, MD	NCT01103297
ACIS	A Focused Registry on Anterior Cervical Interbody Spacer ACIS	Robert Hes, MD	NCT02016794
FR TFNA	A Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) - TFNA System in Patients With Proximal Inter-, Per- or Subtrochanteric Fractures	Prof Michael Blauth	NCT02305121
ProFHER	ProFHER Trial critical appraisal	Simon Lambert	n/a
FR QSP	A prospective and retrospective, multicenter registry for surgeon-based evaluation of the "Quadrilateral Surface Plate" used for acetabular fractures	Tim Pohlemann	NCT01839565
INFINITI (Infection India)	(Infection India) Infection rates following internal fixation of open and closed tibia fractures in india (INFINITI): a prospective multi-center observational study	Prakash J Doshi, MD	NCT01691599
CIOS	Incidence of complications after instrumentatiom of the opsteoporotic spine: a systematic review	Prof Frank Kandziora	n/a
FR SmartFix	Data collection with a novel biofeedback technology for continuous monitoring of bone healing (FR SmartFix)	Dankward Hoentzsch	NCT02094209
FR TFNA	A focused registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™)– TFNA system in patients with proximal inter-, per- or subtrochanteric fractures	Michael Blauth	NCT02305121
PFNA Augmentation	Comparison of Proximal Femoral Nail Antirotation (PFNA) versus PFNA Augmentation for the treatment of closed unstable trochanteric fractures – A randomized-controlled trial (PFNA Augmentation)	Christian Kammerlander	NCT01473082
Pilon	Quality of fracture reduction and its influence on functional results in patients with pilon fractures	Christoph Sommer, MD	NCT01316289
SmartFix II - Moticon	A prospective case series study to monitor healing progression and real life weight bearing after tibial fracture using smart biofeedback systems	Stefan Döbele	NCT03166267
TFNA weight bearing	A prospective study to investigate postoperative real life weight bearing measured in patients treated with a Trochanter Fixation Nail Advanced	Michael Blauth, Karl Stoffel	NCT03160508
FR Tomofix	A focused registry on the conservative treatment of osteoarthritis of the knee	Takeshi Sawaguchi	NCT02077647

AO Education Institute

Short title	Project title	Principal Coordinating Investigator	Clin.Trial.gov NCT number
PI-Program	Optimizing intraoperative imaging during proximal femur fracture fixation- a performance improvement program for surgeons	Andreas Platz	NCT02272972

AO Research Institute

Short title	Project title	Principal Coordinating Investigator	Clin.Trial.gov NCT number
SmartFix I	Clinical data collection with a novel biofeedback technology for continuous monitoring of bone healing	Dankward Höntzsch	NCT02094209
Moticon SmartFix II	A prospective case series study to monitor healing progression and real life weight bearing after tibial fracture using smart biofeedback systems	Stefan Döbele	NCT03166267

Clinical Evidence Completed Studies

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