Clinical Trials Logo
  1. Home
  2. Tibial Fractures
  3. NCT05022485

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

Tibial Fractures Clinical Trial

Official title:
Performance, Safety and Clinical Benefits of a Noble Metal Alloy-coated Intramedullary Nail: a Multicenter, Prospective Trial With a Retrospective Control

Clinical Trial Summary

Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation. The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.

Clinical Trial Description

This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study with retrospective controls. The study will enroll patients that will be implanted with the Zimmer Natural Nail Bactiguard Tibia device and retrospective controls implanted with standard titanium-alloy tibia nails. 500 tibias will be recruited at maximum 15 sites and allocated on a 1:1 ratio into an: - investigational group (prospective/consecutive series of 250 tibias treated with ZNN Bactiguard tibia) - a control group (retrospective series of 250 tibias treated with uncoated titanium-alloy tibia nail - data collection will be retrospective, these subjects will not have to undergo any study-related procedure). The primary endpoint is the Fracture Related Infection (FRI) rate in the study population 12 months after fracture fixation. The secondary endpoint is the confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation through the following measure systems: - Radiologic (RUST) & clinical (FIX-IT) fracture healing 12 months after fracture fixation (performance). - Patients' outcomes assessed by the Oxford Knee Score 12 months after fracture fixation (clinical benefits). - EQ5D-5L (patients' quality of life). - Incidence and frequency of adverse events (safety). Data will be collected at 2 weeks, 3 months, 6 months and 1 year after fracture fixation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05022485
Study type Observational
Source Zimmer Biomet
Contact Paolo Rusconi
Phone +41 798856425
Email paolo.rusconi@zimmerbiomet.com
Status Recruiting
Phase
Start date April 11, 2022
Completion date July 2027
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05459038 - Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures. N/A
Terminated NCT02845245 - Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques N/A
Completed NCT02456194 - Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial N/A
Terminated NCT00667849 - Trial to Evaluate UltraSound in the Treatment of Tibial Fractures N/A
Completed NCT01132508 - Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures N/A
Completed NCT00512434 - Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture N/A
Completed NCT00161616 - Study Evaluating InductOs in Diaphyseal Tibia Fractures Phase 4
Terminated NCT03881241 - Safety Study of Treatment of Leg Fractures
Completed NCT02750072 - INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia N/A
Completed NCT04015167 - A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
Recruiting NCT06451510 - Knee Osteoarthritis in the Region of Norrbotten
Completed NCT05613257 - Distal Targeter vs Free-hand N/A
Completed NCT03388879 - Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures N/A
Completed NCT02491047 - Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures N/A
Completed NCT01797640 - Intramedullary Nailing of Tibia Fractures N/A
Recruiting NCT03232216 - Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate? N/A
Withdrawn NCT03826784 - Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures Phase 3
Terminated NCT00253981 - Light Therapy in the Treatment of Leg Pain N/A
Completed NCT05303389 - Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures N/A
Recruiting NCT05272631 - Depuy Synthes Lower Extremity Shaft Nail Registry