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Long-term Coated and Non-coated Tibia Nails

NCT ID: NCT04576052

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

620 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-18

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Implant Infection

Keywords

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fracture associated infection antibiotic coating infection prophylaxis tibia nail fracture long bone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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antibiotic-coating

patients who have been treated with an antibiotic-coated nail for tibia-fracture

No interventions assigned to this group

non-coated

patients who have been treated with a non-coated nail for tibia fracture

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Synthes GmbH

INDUSTRY

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J. Raschke, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Steffen Roßlenbroich, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Locations

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Universtiy Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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DPS-TCMF-2017-042

Identifier Type: OTHER

Identifier Source: secondary_id

Protect longterm

Identifier Type: -

Identifier Source: org_study_id