Long-term Coated and Non-coated Tibia Nails
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04576052|
Recruitment Status : Enrolling by invitation
First Posted : October 5, 2020
Last Update Posted : May 18, 2022
|Condition or disease|
The primary objective is to assess the proportion of patients who experienced a surgical site infection. Surgical site infection is defined as either deep or superficial. The presence of tibia infection will be defined by the criteria of CDC.
- Proportion of patients with reoperation (secondary procedures)
- Bone union (until radiographically healed)
- Proportion of patients with complications / Adverse Events related to implant or surgery
- Only Subgroup: WOMAC-Score, AOFAS, SF36, EQ5D.
Hypothesis and Statistical considerations and estimated enrollment:
We hypothesize that with the use of antibiotic coating implants like the ETN/ UTN-PROtect the risk of implant-associated infections and osteomyelitis is reduced in treatment of Tibia fractures or in cases of revision surgery in the tibia. In a retrospective manner the implanted gentamicin-coated and uncoated tibia nail procedures are evaluated. In the subgroup of patients with a currently implanted gentamicin-coated nail the incidence of surgical site infection and implant-associated infections will be assessed prospectively.
This study is exploratory in nature. Therefore, there is no formal statistical hypothesis and no formal sample size calculation. Approximately 620 tibial shaft fractures are expected to be included in the 12 months enrollment period.
Data will be analyzed with the use of simple summary statistics. Depending on the volume and quality of the collected data, different statistical analyses will be applied. Exploratory analyses will be conducted to investigate relationships between the different treatment options and the outcomes.
|Study Type :||Observational|
|Estimated Enrollment :||620 participants|
|Official Title:||Antibiotic-coated and Uncoated Titanium Nails in Tibia Fractures and Revision Cases Retrospective Cohort Study/ Long-term Clinical Follow-up|
|Actual Study Start Date :||July 18, 2020|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
patients who have been treated with an antibiotic-coated nail for tibia-fracture
patients who have been treated with a non-coated nail for tibia fracture
- infection [ Time Frame: 15 years maximum ]Occurrence and time-point of surgical site infection
- fracture consolidation [ Time Frame: 15 years maximum ]Number of patients with radiographically confirmed bone healing
- complications/Adverse Events related to implant or surgery [ Time Frame: 15 years maximum ]The occurrence, type, and date of complications/Adverse Events related to implant or surgery
- Duration of postoperative immobilization and non-weight bearing [ Time Frame: 15 years maximum ]Duration of postoperative immobilization and non-weight bearing as documented in the patient chart
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576052
|Universtiy Hospital Muenster|
|Münster, NRW, Germany, 48149|
|Principal Investigator:||Michael J. Raschke, Prof. Dr.||University Hospital Muenster|
|Principal Investigator:||Steffen Roßlenbroich, Dr.||University Hospital Muenster|