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Pseudarthrosis clinical trials

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NCT ID: NCT06098157 Recruiting - Pseudarthrosis Clinical Trials

Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities

TRUFFLE
Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

TRUFFLE is a register of clinical patient data of failed bone healing and bone non-union after fracture. All patients suffering from a long bone delayed or non-union after fracture and undergoing revision surgery are registered with their clinical data, comorbidities, medication, soft tissue status, radiographic status, Non-Union Scoring System (NUSS) Score and are followed up until final bone healing or end of treatment. The register consists of more than 800 patients cases. The aim is to identify risk factors for healing of non-unions. Data analysis will compare those patients that undergo regular healing to those of insufficient healing.

NCT ID: NCT05583864 Recruiting - Spondylolisthesis Clinical Trials

Lumbar Fusion With Porous Versus Non-Porous Cages

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: 1. Porous titanium cages 2. Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.

NCT ID: NCT05483387 Recruiting - Arthrosis Clinical Trials

Prospective Post-market Clinical Follow-up Study of the HBS 2 Resorb Mg in Patients With Intra- and Extraarticular Fractures, Pseudarthroses and Arthrodesis of Small Bones and Bone Fragments.

Start date: November 1, 2022
Phase: Phase 4
Study type: Interventional

This study is a multi-centre, prospective, clinical observational study to evaluate the CE-marked HBS 2 Resorb Mg screws under routine conditions. The device will be used according to its intended use. The data collected for this study does only include measurements which are standard of care.

NCT ID: NCT05183542 Recruiting - Clinical trials for Pseudoarthrosis of Bone

SPECT/CT Bone Scan Quantification Surgery

PERQUAL
Start date: April 29, 2022
Phase: N/A
Study type: Interventional

The hypothesis of our study is that SPECT/CT bone scan fixation quantified by SUVMAX on a CZT solid state camera preoperatively would identify good responders to lumbar arthrodesis surgery.

NCT ID: NCT05049915 Recruiting - Clinical trials for Pseudoarthrosis of Bone

Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Tibia and Femur Non-unions

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Abstract Background: Treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. Therefore, artificial bone graft substitutes that might replace autologous bone are needed. S53P4-type bioactive glass (BaG) is a promising material which might be used as bone graft substitute due to its osteostimulative, conductive and antimicrobial properties. In this study, the investigators plan to examine the clinical effectiveness of BaG as a bone graft substitute in Masquelet therapy in comparison with present standard Masquelet therapy using an ABG with tricalciumphosphate to fill the bone defect. Methods/design: This randomized controlled, clinical non-inferiority trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University. Patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2-5 cm and who are receiving Masquelet treatment will be included in the study. The resulting bone defect will either be filled with autologous bone and tricalciumphosphate (control group, N = 25) or BaG (S53P4) (study group, N = 25). Subsequent to operative therapy, all patients will receive the same standardized follow-up procedures. The primary endpoint of the study is union achieved 1year after surgery. Discussion: The results from the current study will help evaluate the clinical effectiveness of this promising biomaterial in non-union therapy. In addition, this randomized trial will help to identify potential benefits and limitations regarding the use of BaG in Masquelet therapy. Data from the study will increase the knowledge about BaG as a bone graft substitute as well as identify patients possibly benefiting from Masquelet therapy using BaG and those who are more likely to fail, thereby improving the quality of non-union treatment.

NCT ID: NCT04848376 Recruiting - Trauma Clinical Trials

Post-Market Clinical Follow-up Study of A-SPINE's Products

Start date: September 9, 2019
Phase:
Study type: Observational

This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.

NCT ID: NCT04601363 Recruiting - Clinical trials for Degenerative Disc Disease

Personalized Spine Study Group (PSSG) Registry

PSSG
Start date: October 29, 2020
Phase:
Study type: Observational

The primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. The secondary objective is to collect clinical and radiographic outcomes of patients with hardware as a control cohort to the patient-specific rods.

NCT ID: NCT03970941 Recruiting - Pseudarthrosis Clinical Trials

Two-stage Treatment of Large Bone Defects With Cerament® G and Cerament® V Plus Auto and/or Allograft Using the Masquelet Technique as Salvage Therapy After Bone Resection in Patients With Septic Pseudarthrosis

EVIDENCE
Start date: September 5, 2019
Phase:
Study type: Observational

Septic pseudarthrosis of long bones are complications that can unfortunately occur after the consolidation of a fracture and some situations present risks of superinfection, persistent infection or mechanical failure (30-40% risk of complications) that can lead to amputation. A possible saving situation used by CRIOAC ("Centre de Référence des Infections Ostéo-Articulaires Complexes") is the use of a bone substitute impregnated with an antibiotic allowing a high local concentration of this antibiotic. The aim of this study is to evaluate the cost of management of septic pseudarthrosis with two-stage treatment and CERAMENT® and the quality of life for this patients.

NCT ID: NCT03257826 Recruiting - Clinical trials for Congenital Pseudarthrosis of Tibia

The Effect of Percutaneous Kirschner Wire Technique in Management of CPT Under One Year Old

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This study was to determine the union rates of congenital pseudarthrosis in children operated before 1 year of age to identify growth abnormalities in the affected limb ,including ankle valgus,tibia valgus,and shortening.

NCT ID: NCT02896114 Recruiting - Clinical trials for Congenital Pseudarthrosis of Tibia

A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China

Start date: September 2016
Phase:
Study type: Observational

The study aims to evaluate the current methods of surgical treatment for Congenital Pseudarthrosis of tibia(CPT) in children and their results respectively.