Long-term Coated and Non-coated Tibia Nails

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

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.

Study Overview

• Status: Completed
• Conditions: Implant Infection

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.

• Study Type: Observational
• Enrollment (Actual): 397

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universtiy Hospital Muenster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with implantation of a tibial nail to for fracture management or revision surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
antibiotic-coating; patients who have been treated with an antibiotic-coated nail for tibia-fracture
non-coated; patients who have been treated with a non-coated nail for tibia fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infection	Occurrence and time-point of surgical site infection	15 years maximum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fracture consolidation	Number of patients with radiographically confirmed bone healing	15 years maximum
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
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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Synthes GmbH
• Investigators: Principal Investigator: Steffen Roßlenbroich, Dr., University hospital Muenster; Principal Investigator: Michael J. Raschke, Prof. Dr., University hospital Muenster

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2020
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: fracture associated infection; antibiotic coating; infection prophylaxis; tibia nail; fracture long bone
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: Protect longterm; DPS-TCMF-2017-042 (Other Identifier: Synthes Gmbh)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No