Long-term Coated and Non-coated Tibia Nails

Implant Infection Clinical Trial

Official title:

Antibiotic-coated and Uncoated Titanium Nails in Tibia Fractures and Revision Cases Retrospective Cohort Study/ Long-term Clinical Follow-up

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04576052
• Other study ID #: Protect longterm
• Secondary ID: DPS-TCMF-2017-04
• Status: Enrolling by invitation
• Start date: July 18, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

For this retrospective cohort study, medical records of patients treated between 2005 to 2019 with the UTN PROtect and/or ETN PROtect for tibia fractures or tibia revision cases will be examined. In comparison to this cohort, patients who received an uncoated tibia nail are examined as well. Demographics, pre-surgical health status, details on fracture type or on revision, treatment decision and surgery details, postoperative reoperation and revision, surgical site infections, time to union, and adverse events will be registered. In a subgroup, additional information including clinical outcomes and patient satisfaction will be assessed by clinical exam. Patients who still carry a nail and feel discomfort at the surgical site or present with a medical condition which demands an imaging will receive an x-ray of the tibia. The xray is not part of the standard study protocol.

Description:

Primary Objective:

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.

Secondary Objective(s):

• 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 620
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary tibial shaft fracture (fracture type 42 according to the AO/OTA Fracture and Dislocation Classification) treated operatively with an intramedullary nail as Standard of care.

• Signed informed consent, if required by IRB/EC

Exclusion Criteria:

• Prisoner at date of inclusion

Related Conditions & MeSH terms

• Implant Infection
• Infections

Locations

Country	Name	City	State
Germany	Universtiy Hospital Muenster	Münster	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Synthes GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infection	Occurrence and time-point of surgical site infection	15 years maximum
Secondary	fracture consolidation	Number of patients with radiographically confirmed bone healing	15 years maximum
Secondary	complications/Adverse Events related to implant or surgery	The occurrence, type, and date of complications/Adverse Events related to implant or surgery	15 years maximum
Secondary	Duration of postoperative immobilization and non-weight bearing	Duration of postoperative immobilization and non-weight bearing as documented in the patient chart	15 years maximum