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Long-term Coated and Non-coated Tibia Nails

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04576052
Recruitment Status : Enrolling by invitation
First Posted : October 5, 2020
Last Update Posted : May 18, 2022
Synthes GmbH
Information provided by (Responsible Party):
University Hospital Muenster

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 620 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Antibiotic-coated and Uncoated Titanium Nails in Tibia Fractures and Revision Cases Retrospective Cohort Study/ Long-term Clinical Follow-up
Actual Study Start Date : July 18, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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

Primary Outcome Measures :
  1. infection [ Time Frame: 15 years maximum ]
    Occurrence and time-point of surgical site infection

Secondary Outcome Measures :
  1. fracture consolidation [ Time Frame: 15 years maximum ]
    Number of patients with radiographically confirmed bone healing

  2. complications/Adverse Events related to implant or surgery [ Time Frame: 15 years maximum ]
    The occurrence, type, and date of complications/Adverse Events related to implant or surgery

  3. Duration of postoperative immobilization and non-weight bearing [ Time Frame: 15 years maximum ]
    Duration of postoperative immobilization and non-weight bearing as documented in the patient chart

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04576052

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Universtiy Hospital Muenster
Münster, NRW, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Synthes GmbH
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Principal Investigator: Michael J. Raschke, Prof. Dr. University Hospital Muenster
Principal Investigator: Steffen Roßlenbroich, Dr. University Hospital Muenster
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Responsible Party: University Hospital Muenster Identifier: NCT04576052    
Other Study ID Numbers: Protect longterm
DPS-TCMF-2017-042 ( Other Identifier: Synthes Gmbh )
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
fracture associated infection
antibiotic coating
infection prophylaxis
tibia nail
fracture long bone
Additional relevant MeSH terms:
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