Long-term Coated and Non-coated Tibia Nails

University Hospital Muenster

Status

Invitation-only

Conditions

Implant Infection

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04576052

DPS-TCMF-2017-042 (Other Identifier)

Protect longterm

Details and patient eligibility

About

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.

Full 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.

Enrollment

620 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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