NCT05276674

Brief Summary

Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Oct 2023Dec 2027

First Submitted

Initial submission to the registry

March 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

March 2, 2022

Last Update Submit

February 2, 2026

Conditions

Femoral Fracture

Keywords

BactiguardFemur fractureIntramedullary nailingInfection control

Outcome Measures

Primary Outcomes (1)

  • Rate of fracture healing 12 months after fracture fixation

    Fracture healing is assessed with x-ray imaging and clinical examination. Radiographic Union-Scale in Tibial fractures (RUST) score adapted for the femur, A/P and lateral views. Range: 4 - 12. Fracture healing is defined as RUST scores greater than or equal to 6. Fix-IT score (clinical examination). Range 0 - 12, higher scores indicate better limb function.

    3, 6, and 12 months after fracture fixation

Secondary Outcomes (4)

  • Oxford Knee Score (limb function)

    3, 6, and 12 months after fracture fixation

  • EQ-5D-5L score (patient's quality of life)

    pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation

  • Adverse events frequency

    12 months after fracture fixation

  • Rate of fracture-related infections

    12 months after fracture fixation

Study Arms (1)

ZNN Bactiguard Retrograde Femoral Nail

Patients implanted with a ZNN Bactiguard Retrograde Femoral Nail for fixing and stabilizing a femoral fracture.

Device: ZNN Bactiguard Retrograde Femoral Nail

Interventions

ZNN Bactiguard Retrograde Femoral NailDEVICE

Femoral fracture internal fixation.

ZNN Bactiguard Retrograde Femoral Nail

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive series of 18-year-old patients or older with femur fractures implanted with a ZNN Bactiguard Retrograde Femoral Nail according to the approved/cleared indications.

You may qualify if:

  • Patients must be 18 years or older.
  • Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling / high energy trauma followed by definitive treatment by intramedullary nail) can also be included.
  • Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde Femoral Nail.
  • Patient must be able and willing to complete the protocol required follow-up.
  • Patient must have a signed EC approved consent.
  • Patients capable of understanding the surgeon's explanations and following his instructions.

You may not qualify if:

  • Skeletally immature patients
  • A medullary canal obliterated by a previous fracture or tumor
  • Bone shaft having excessive bow or a deformity
  • Lack of bone substance or bone quality, which makes stable seating of the implant impossible
  • All concomitant diseases that can impair the operation, functioning or the success of the implant
  • Insufficient blood circulation
  • Infection
  • Patient is unwilling or unable to give consent.
  • Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol/drug addiction, known to be pregnant or breast feeding).
  • Patient anticipated to be non-compliant and/or likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).
  • Not expected to survive the duration of the follow-up program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitario Ntra. Sra. de Candelaria

Santa Cruz de Tenerife, Tenerife, 38010, Spain

ACTIVE NOT RECRUITING

Leeds General Infirmary

Leeds, LEEDS, LS1 3EX, United Kingdom

RECRUITING

Manchester Royal Infirmary

Manchester, United Kingdom

RECRUITING

Stepping Hill Hospital

Stockport, United Kingdom

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Central Study Contacts

Gemma de Ramon Francàs

CONTACT

+41 79 377 11 96gemma.deramonfrancas@zimmerbiomet.com

Emilie Rohmer

CONTACT

+41 79 368 91 28emilie.rohmer@zimmerbiomet.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 11, 2022

Study Start

October 23, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

ES(1)GB(3)