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Clinical Evidence by Therapeutic Area
The results of research studies utilizing Orthofix products and technologies have been published in a variety of forums, including scholarly journals. Some of these works are highlighted below under their respective therapeutic area.
Bone Growth Therapies
With almost 40 years of healing patients, our bone growth therapy devices are the number one prescribed bone growth stimulators in the U.S. These devices provide patients with safe, non-surgical treatment options for promoting spinal fusion and healing nonunion fractures. Using Orthofix’s pulsed electromagnetic field (PEMF) technology, the devices generate a uniform, low-level electrical field that helps activate and augment the body’s natural healing process to enhance bone fusion.
- Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion
- A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions
- Long-term follow-up of fracture nonunions treated with PEMFs
- Pulsed electromagnetic field stimulation may improve fusion rates in cervical arthrodesis in high-risk populations
- Pulsed electromagnetic fields for the treatment of tibial delayed unions and nonunions. A prospective clinical study and review of the literature
- Spine fusion for discogenic low back pain: outcomes in patients treated with or without pulsed electromagnetic field stimulation
- Three-and 4-level lumbar arthrodesis using adjunctive pulsed electromagnetic field stimulation: a multicenter retrospective evaluation of fusion rates and a review of the literature
- Pseudarthrosis after lumbar spine fusion: nonoperative salvage with pulsed electromagnetic fields
- Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study
Biologics
Orthofix and IsoTis biologics are engineered to facilitate bony fusion for spine, orthopedics, and other surgical applications. Our comprehensive portfolio of industry-leading bone grafts, including cellular bone allografts, premium fiber and putty DBMs, advanced bioactive synthetics, and procedural solutions, are validated by rigorous peer-reviewed research studies, demonstrating robust bone growth and successful clinical outcomes.
- Efficacy, Cost, and Complications of Demineralized Bone Matrix in Instrumented Lumbar Fusion: Comparison With rhBMP-2
- Posterolateral lumbar spine fusion using a novel demineralized bone matrix: a controlled case pilot study
- Comparison of cortical ring allograft and plate fixation with autologous iliac bone graft for anterior cervical discectomy and fusion
- A clinical study on bone formation using a demineralized bone matrix and resorbable membrane
- Comparative Efficacy of 2 Different Demineralized Bone Matrix Allografts in Treating Long-Bone Nonunions in Heavy Tobacco Smokers
- Use of Demineralized Bone Matrix in Ankle/Hindfoot Fusion
- Efficacy of contained metaphyseal and periarticular defects treated with two different demineralized bone matrix allografts
- High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach
- Impact of surgical risk factors for non-union on lumbar spinal fusion outcomes using cellular bone allograft at 24-months follow-up
- Radiographic Fusion Outcomes for Trinity Cellular Based Allograft versus Local Bone in Posterolateral Lumbar Fusion
- Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion
- Twelve-Month Results from a Prospective Clinical Study Evaluating the Efficacy and Safety of Cellular Bone Allograft in Subjects Undergoing Lumbar Spine Fusion
- Clinical evaluation of an allogeneic bone matrix containing viable osteogenic cells in patients undergoing one- and two-level posterolateral lumbar arthrodesis with decompressive laminectomy
- Efficacy of an allograft cellular bone matrix as an alternative to autograft in anterior cervical discectomy and fusion: radiological results & safety
- Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution® Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion
- A prospective clinical and radiographic 12-month outcome study of patients undergoing single-level anterior cervical discectomy and fusion for symptomatic cervical degenerative disc disease utilizing a novel viable allogeneic, cancellous, bone matrix (trinity evolution™) with a comparison to historical controls
- Radiographical outcomes of a cellular based allograft following foot/ankle arthrodesis in patients with risk for non-union
- Prospective, Multicenter Evaluation of Allogeneic Bone Matrix Containing Viable Osteogenic Cells in Foot and/or Ankle Arthrodesis
- A Retrospective Clinical Comparison of Two Allogeneic Bone Matrices Containing Viable Osteogenic Cells in Patients Undergoing Foot and/or Ankle Arthrodesis
- Examination of the Role of Cells in Commercially Available Cellular Allografts in Spine Fusion: An in Vivo Animal Study
- In-vivo Performance of Seven Commercially Available Demineralized Bone Matrix Fiber and Putty Products in a Rat Posterolateral Fusion Model
Limb Reconstruction
Orthofix offers innovative and minimally invasive limb reconstruction solutions to help surgeons improve their patient’s quality of life. Designed to address the lifelong bone and joint health needs of patients of all ages, our limb reconstruction products help patients achieve a more active and mobile lifestyle when compared to other surgical solutions. Our well-rounded product lines offer comprehensive solutions for Limb Preservation, Extremity Deformity Correction, Limb Lengthening and Complex Fracture Management.
- Intramedullary leg lengthening with a motorized nail
- Functional results of lower extremity lengthening by motorized intramedullary nails
- Lengthening in Congenital Femoral Deficiency: A Comparison of Circular External Fixation and a Motorized Intramedullary Nail
- Gain of length-loss of strength? Alteration in muscle strength after femoral leg lengthening in young patients: a prospective longitudinal observational study
- Complications and Effectiveness of Intramedullary Limb Lengthening: A Matched Pair Analysis of Two Different Lengthening Nails
- Femoral lengthening with a motorized intramedullary nail
- Leg lengthening with a motorized nail in adolescents: an alternative to external fixators?
- Long-term effects of retrograde approach on the knee after motorized femoral limb lengthening
- Treatment of complex foot deformities with hexapod external fixator in growing children and young adult patients.
- Evaluation of the external fixator TrueLok Hexapod System for tibial deformity correction in children.
- Can the TrueLok Hexapod System™ be used to accurately correct lower limb deformity in children?
- Orthoplastic consideration during distal tibia deformity and limb lengthening utilizing truelok hexapod circular external fixator.
- Correction of complex lower limb angular deformities with or without length discrepancy in children using the TL-HEX hexapod system: Comparison of clinical and radiographical results.
- Gradual Deformity Correction with a Computer-assisted Hexapod External Fixator in Blount’s Disease.
- Computer-Assisted Gradual Correction of Charcot Foot Deformities: An In-Depth Evaluation of Stage One of a Planned Two-Stage Approach to Charcot Reconstruction.
- Congenital dislocation of the knee in a three-year-old-child with Larsen syndrome: Treatment with a hexapod-type external fixator.
- Femoral locking plate failure salvaged with hexapod circular external fixation: a report of two cases.
- A Variant of Madelung Deformity: Management of the Distal Ulna Within the Carpal Canal.
- Preliminary results using patient-specific 3d printed models to improve preoperative planning for correction of post-traumatic tibial deformities with circular frames.
- Tibial pilon fractures treated with a periarticular external fixator: Retrospective study of 47 cases
- Outcomes following treatment of complex tibial fractures with circular external fixation: A comparison between the taylor spatial frame and TrueLok-Hex
- Management of Osseous Defects of the Tibia Utilizing Orthofix Hexapod Circular External Fixator: A Technique Guide-An Orthoplastic Approach for Combined Soft Tissue and Osseous Defects
- Temporary circular external fixation for spanning the traumatised ankle joint: A cohort comparison study
- Combination of Open Subtotal Calcanectomy and Stabilization With External Fixation as Limb Salvage Procedure in Hindfoot-Infected Diabetic Foot Ulcers
- Deformity correction in pediatric skeletal dysplasia: treatment challenges and solutions.
- Increased Arthrodesis Rates in Charcot Neuroarthropathy Utilizing Distal Tibial Distraction Osteogenesis Principles
- Nonunion After an Open Trimalleolar Ankle Fracture: An Extended Clinical Course and a Novel Approach to Tibio-Talo-Calcaneal Arthrodesis
- Management of Osseous Defects in the Tibia: Utilization of External Fixation, Distraction Osteogenesis, and Bone Transport
- The Management of Soft Tissue and Bone Loss in Type IIIB and IIIC Pediatric Open Tibia Fractures
- Clinical translation of a patient-specific scaffold-guided bone regeneration concept in four cases with large long bone defects
- Treatment of Periprosthetic Humeral Shaft Fracture after Total Elbow Arthroplasty in an Osteoporotic Patient, using the Ilizarov External Ring Fixator: A Case Report
- Treatment of genu valgum in children by means of temporary hemiepiphysiodesis using eight-plates: short-term findings
- Growth modulation by hemi epiphysiodesis using eight-plate in Genu valgum in Paediatric population
- Guided growth: preliminary results of a multinational study of 967 physes in 537 patients
- Does eight-plate epiphysiodesis of the proximal tibia in treating angular deformity create intra-articular deformity?
- Temporary hemiepiphysiodesis using an eight-plate implant for coronal angular deformity around the knee in children aged less than 10 years: efficacy, complications, occurrence of rebound and risk factors
- Guided growth using a tension-band plate in Blount’s disease
- Angular Deformities of the Knee in Children Treated with Guided Growth
- Outcomes of Temporary Hemiepiphyseal Stapling for Correcting Genu Valgum in Children with Multiple Osteochondromas: A Single Institution Study
- The Challenges of Monoaxial Bone Transport in Orthopedics and Traumatology
- The treatment of femoral bone loss by axial external fixation and susbequent locking plate application: a case report
- Bone elongation using monolateral external fixation: a practical guide
- Outcome of oscillating saw open osteotomy in two-stage lower extremity bone transport with monolateral frame
- Reconstruction of femoral bone loss with a monoplane external fixator and bone transport
- Simultaneous Bilateral Femoral and Tibial Lengthening in Achondroplasia
- Monolateral external fixation for the progressive correction of neurological spastic knee flexion contracture in children
- Simultaneous bilateral lengthening of femora and tibiae in achondroplastic patients
- Bone lengthening with extra-articular arthrodesis of the hip using external fixation
- Modified osteotomy for treatment of forearm deformities (Masada IIb) in hereditary multiple osteochondromas: a retrospective review
- The Challenges of Monoaxial Bone Transport in Orthopedics and Traumatology
- Reconstruction of femoral bone loss with a monoplane external fixator and bone transport
- Fracture treatment in children–data analysis and follow-up results of a prospective study
- External fixation of children’s fractures: use of the Orthofix Dynamic Axial Fixator
- Comparative study of high tibial osteotomy using dynamic axial fixator and locked low-profile plate in medial osteoarthritis of knee
- Patellar tendon length following opening wedge high tibial osteotomy using an external fixator with particular reference to later total knee replacement.
- The treatment of distal third humeral diaphyseal fractures: Is there still a place for the external fixation?
- Results of External Fixation and Metatarsophalangeal Joint Fixation With K-Wire in Brachymetatarsia
- Mini-Invasive Treatment for Brachymetatarsia of the Fourth Ray in Females: Percutaneous Osteotomy With Mini-Burr and External Fixation-A Case Series
- Treatment of equinocavovarus deformity in a severely hemophilic child: the role of a monolateral multiplanar-geared fixation device
- Shortening and deformity of radius and ulna in children: correction of axis and length by callus distraction.
- Callus distraction with external fixator for the treatment of congenital brachymetatarsia of the fourth ray.
- Ulnar Distraction Osteogenesis in the Treatment of Forearm Deformities in Children With Multiple Hereditary Exostoses
- Callus distraction for brachymetatarsia – A comparison between an internal device and the external fixator
- Alternative method for thumb reconstruction. Combination of 2 techniques: metacarpal lengthening and mini wraparound transfer
- Management of intra-articular fracture of the fingers via mini external fixator combined with limited internal fixation
- Comparison of plate, calcanealplasty and external fixation in the management of calcaneal fractures
- Heel displaced intra-articular fractures treated with mini-calcaneal external fixator
- Association between CT imaging at follow-up and clinical outcomes in heel fractures
- External fixation for displaced intra-articular fractures of the calcaneum
- Ultrasonically driven instruments in the transfemoral approach–an aid to preservation of bone stock and reduction of implant length
- Long-term outcomes of cement in cement technique for revision endoprosthesis surgery
- The use of a long stem cemented femoral component in revision total hip replacement: a follow-up study of five to 16 years
- The polished tri-tapered stem for cement-in-cement revision hip arthroplasty, a reliable and reproducible technique?
- Management of Vancouver B2 and B3 Periprosthetic Proximal Femoral Fractures by Distal Locking Femoral Stem (Cannulok) in Patients 75 Years and Older
- Shoulder function and pain level after revision of failed reverse shoulder replacement to hemiarthroplasty
- Thermal tissue damage caused by ultrasonic cement removal from the humerus
- Cortical Fenestration for Megaprosthesis Stem Revision
- Constrained captive acetabular cup for recurrent dislocation of hemiarthroplasty in elderly: A case series
- A sophisticated antibiotic-loading protocol in articulating cement spacers for the treatment of prosthetic joint infection: A retrospective cohort study
- Outcome of complex fractures of the tibial plateau treated with a beam-loading ring fixation system
- Tibial fractures treated with circular fixation: does the use of olive wires at the fracture site improve healing?
- Treatment of osteochondral lesions of the talus with cryopreserved talar allograft and ankle distraction with external fixation
- Displaced Intra-Articular Fractures of the Distal Radius: Open Reduction With Internal Fixation Versus Bridging External Fixation
- External fixation is more suitable for intra-articular fractures of the distal radius in elderly patients
- Comparison of the volar locking plate and the bridging external fixator in the treatment of distal radius fracture based on range of wrist motion assessed by functional radiography
- Minimally invasive percutaneous compression plating versus dynamic hip screw for intertrochanteric fractures: a randomized control trial
- Long-term results after treatment of pertrochanteric femoral fractures with percutaneous compression plate (PCCP)
- Mid-term results after treatment of intertrochanteric femoral fractures with percutaneous compression plate (PCCP)
- Comparison of Outcomes of Intertrochanteric Fracture Fixation Using Percutaneous Compression Plate Between Stable and Unstable Fractures in the Elderly
- Comparison of percutaneous compression plating and short reconstruction nail for treatment of intertrochanteric fracture
- Clinical and functional outcomes of the PCCP study: a multi-center prospective study in Italy
- A comparative study between gamma nail and percutaneous compression plating for the treatment of intertrochanteric hip fractures
- Results of transarticular fixator application in distal radius fractures
- Dynamic vs static external fixation of distal radial fractures: A randomized study
- Cast vs external fixation: a comparative study in elderly osteoporotic distal radial fracture patients
- Clinical results of external fixation for unstable Colles’ fractures
- The Treatment Method and Results of Percutaneous Pinning and Dynamic External Fixator Application for Unstable Distal Radius Fractures
- Reduction techniques in distal radius fractures
- Chronic perilunate dislocations treated with open reduction and internal fixation: results of medium-term follow-up
- Management of missed Monteggia fractures with ulnar osteotomy, open reduction, and dual-socket external fixation
- Comparison between external fixators and fixed-angle volar-locking plates in the treatment of distal radius fractures
- Distraction osteogenesis of fourth brachymetatarsia
- A new technique for closed management of displaced intra-articular fractures of metacarpal and phalangeal head delayed on presentation: report of eight cases
- Distraction for proximal interphalangeal joint contractures: long-term results
- Treatment of Rolando fracture by capsuloligamentotaxis using mini external fixator: a report of 16 cases
- Shortening and deformity of radius and ulna in children: correction of axis and length by callus distraction
- The use of minimally invasive fixation in fractures of the hand–the minifixator concept
- Functional outcome with special attention to the DASH questionnaire following callus distraction and phalangization of the thumb after traumatic amputation in the middle one-third
- Management of intra-articular fracture of the fingers via mini external fixator combined with limited internal fixation
- Distraction correction of chronic flexion contractures of PIP joint: comparison between two distraction rates
- Ball-joint versus single monolateral external fixators for definitive treatment of tibial shaft fractures
- Treatment of femoral shaft fractures with monoaxial external fixation in polytrauma patients
- External fixators for open fractures of tibia and fibula in patients with haemophilia A
- External fixation as a primary and definitive treatment for tibial diaphyseal fractures
- Controlled Double Gradual Opening Osteotomy for the Treatment of Severe Varus of the Knee-Blount’s Disease
- Lateral Gradual Opening Osteotomy of the Tibia With Monolateral External Fixator for Correcting the Valgus Deformity of the Tibia
- One-Stage Closed Intramedullary Nailing for Delayed Femoral Fracture in Multiple Injured Patients
Spine Fixation
We are committed to helping restore quality of life for our patients through advanced interbody and fixation solutions that aid surgeons in repairing spinal alignment, improving disc height, providing nerve decompression and correcting instabilities. Our spine fixation products are used globally in a variety of spine procedures involving deformity correction, minimally invasive approaches, sacroiliac joints, degenerative disc disease, trauma and tumors.
- The use of anterior subcutaneous internal fixation (INFIX) for treatment of pelvic ring injuries in major trauma patients, complications and outcomes
- Three-level anterior cervical discectomy and fusion with plate fixation
- A novel endoscope-assisted technique for lateral lumbar interbody fusion: feasibility study, technical note, and operative video