Long-term Coated and Non-coated Tibia Nails

NCT04576052 | Unknown

• 2 other identifiers: Protect longtermDPS-TCMF-2017-042
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• infection

  Occurrence and time-point of surgical site infection

  15 years maximum

Secondary Outcomes (3)

• fracture consolidation

  15 years maximum

• complications/Adverse Events related to implant or surgery

  15 years maximum

• Duration of postoperative immobilization and non-weight bearing

  15 years maximum

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Synthes GmbH: collaborator

Study Sites (1)

Universtiy Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Study Officials

• Michael J. Raschke, Prof. Dr.

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

• Steffen Roßlenbroich, Dr.

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: July 18, 2020
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)