Clinical trials: Internal Fixation
Hallux Valgus
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.
- Trial name
- PECA (NCT05361317)
- Testing
- Nexis® PECA Bunion device
- Where
- 4 sites in France
- Volunteers
- 86 people
- Sponsor
- Novastep
Acute Postoperative Pain, Chest Wall Surgery
Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis
This prospective single-group study will evaluate a visual analog scale-guided multimodal analgesia algorithm during the first five days after posterior rib remodeling with osteosynthesis.
- Trial name
- NCT07805928
- Testing
- VAS-Guided Multimodal Analgesia Algorithm, Ultrasound-Guided Thoracic Wall Regional Block
- Where
- Colombia
- Volunteers
- 160 people
- Sponsor
- Research Inc
Bunions, Postoperative Pain
Dose-Escalation Study of HTX-034 Following Bunionectomy
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl.
- Trial name
- NCT04398329
- Testing
- HTX-034 low dose, HTX-034 high dose, Luer lock applicator
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Heron Therapeutics
Foot Arthritis
Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel dynamic sustained compression intramedullary nail for subtalar (talocalcaneal) arthrodesis.
- Trial name
- NCT04784156
- Testing
- Subtalar (Talocalcaneal) Arthrodesis, DynaNail Mini
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- MedShape, Inc
Femoral Neck Fracture
Dynamic Internal Fixation of Femoral Neck Fractures
Evaluation of dynamic Plate-Screw-Systems for internal fixation after femoral neck fractures. Open Registry for Comparison of 1-screw-systems (DHS) with multi-screw-system Targon FN.
- Trial name
- DIFINE (NCT00779948)
- Where
- 9 sites in Germany
- Volunteers
- 171 people
- Sponsor
- Aesculap AG
Body Contouring Surgery
RIBOSS-01: Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing
The goal of this observational study is to learn about the long-term effects of RIBOSS intervention and demonstrate non-inferiority of postoperative respiratory function (FEV1, FVC, FEV1/FVC) at 6 months in the RIBOSS group…
- Trial name
- (RIBOSS) (NCT07705295)
- Where
- Colombia
- Volunteers
- 160 people
- Sponsor
- Research Inc
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
Fracture Fixation, Internal, Distal Radius Fracture
RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children
This is a pre-market, single-arm, open-label, monocenter clinical investigation evaluating the safety and performance of the magnesium (Mg)-based bioresorbable RemeOs™ DrillPin for surgical fixation of distal radius fractures in…
- Trial name
- NCT07028541
- Testing
- Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children
- Volunteers
- 20 people
- Sponsor
- Bioretec Ltd.
Orthopedic Disorder
Elbow Outcomes Clinical Study (WELBOW)
WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).
- Trial name
- WELBOW (NCT04173377)
- Where
- 7 sites in Belgium, Canada and 2 more
- Volunteers
- 310 people
- Sponsor
- Stryker Trauma and Extremities
Tibial Delayed Healing
Tibial Delayed Healing Pivotal Clinical Trial
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
- Trial name
- NCT01016067
- Testing
- INFUSE/MASTERGRAFT, Autograft bone
- Where
- 16 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Medtronic Spinal and Biologics
Fractures, Bone, Osteosynthesis
Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures
The goal of this monocenter randomized pilot study is to investigate the usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures.
- Trial name
- ADEPTH-Pilot (NCT05960591)
- Testing
- ADEPTH
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- SLAM Ortho B.V.
Attachment
Effects of Mother-infant Skin-to-skin Contact in Postpartum Women
When a newborn is delivered in good physiological condition, immediate skin-to-skin contact with the mother is required. Skin-to-skin contact has a wide range of benefits for both mother and baby.
- Trial name
- NCT06781307
- Testing
- skin to skin
- Where
- Taiwan
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Jen-Ai Hospital Institutional Review Board
Pathological Fracture of Hip, Bone Metastases
Evaluation of the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture.
- Trial name
- NCT03579212
- Testing
- Y-STRUT® (Hyprevention, Pessac, France)
- Where
- 4 sites in France
- Volunteers
- 16 people
- Sponsor
- Hyprevention
Ankle Arthritis, Foot Arthritis
The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.
- Trial name
- NCT04784273
- Testing
- Tibiotalocalcaneal Arthrodesis, DynaNail
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- MedShape, Inc
Ankle Arthritis, Arthritis Foot
The Use of a Dynamic Sustained Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis utilizing longitudinal weight-bearing computed tomographic…
- Trial name
- NCT04831645
- Testing
- DynaNail, Tibiotalocalcaneal Arthrodesis
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- MedShape, Inc
Tibial Fractures
Safety Study of Treatment of Leg Fractures
This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.
- Trial name
- EVOS SMALL (NCT03881241)
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Smith & Nephew, Inc.
Pathologic Fracture
Performance and Safety of the Innofix® Screw (IF25)
The purpose of this clinical investigation is to collect data about the safety and the performances of the InnoFix® screw : Clinical performances (Pain reduction due to the fracture treatment, maintenance of the stabilizaton of…
- Trial name
- IF25 (NCT06800417)
- Testing
- Percutaneous fixation by internal cemented screw (InnoFix®)
- Volunteers
- 34 people
- Sponsor
- Innoprod Medical
Bacterial Infection
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware.
- Trial name
- NCT02436876
- Testing
- MBN-101
- Where
- 6 sites in United States
- Volunteers
- 29 people
- Sponsor
- Microbion Corporation
Hallux Valgus
Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device
The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus.
- Trial name
- NCT01535144
- Testing
- Fracture compressing screw ZfW 102 Königsee Implantate GmbH, Fracture compressing screw titanium Königsee Implantate GmbH
- Where
- Germany
- Volunteers
- 26 people
- Sponsor
- Syntellix AG
Closed Proximal Tibial Fracture Schatzker I - VI, Closed Proximal Tibial Fracture AO-OTA 41
chronOS Inject in Proximal Tibial Fractures
The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.
- Conditions
- Closed Proximal Tibial Fracture Schatzker I - VI, Closed Proximal Tibial Fracture AO-OTA 41, Closed Proximal Tibial Fracture AO-OTA 42
- Trial name
- NCT02056834
- Testing
- chronOS Inject
- Where
- 2 sites in South Korea
- Volunteers
- 36 people
- Sponsor
- Synthes GmbH