Clinical trial NCT04576052: Long-term Coated and Non-coated Tibia Nails
Official title: Antibiotic-coated and Uncoated Titanium Nails in Tibia Fractures and Revision Cases Retrospective Cohort Study/ Long-term Clinical Follow-up
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Implant Infection
Keywords: fracture associated infection
antibiotic coating
infection prophylaxis
tibia nail
fracture long bone
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Synthes GmbH
First posted: 2020-10-05
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with implantation of a tibial nail to for fracture management or revision surgery

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: infection
timeFrame: 15 years maximum
Secondary outcomes:
measure: fracture consolidation
timeFrame: 15 years maximum
measure: complications/Adverse Events related to implant or surgery
timeFrame: 15 years maximum
measure: Duration of postoperative immobilization and non-weight bearing
timeFrame: 15 years maximum
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Universtiy Hospital Muenster
state: NRW
Study officials:
affiliation: University Hospital Muenster
name: Michael J. Raschke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Muenster
name: Steffen Roßlenbroich, Dr.
role: PRINCIPAL_INVESTIGATOR
References: