Post-market clinical follow-up study for Zimmer femoral nails

Post-market clinical follow-up study to provide safety, performance and clinical benefits data of the Zimmer® Natural Nail® antegrade and retrograde femoral nail (implants and instrumentation) – a retrospective consecutive series study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15234554

Enrollment

Registered

2025-12-18

Start date

2025-03-10

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral shaft fractures Musculoskeletal Diseases

Interventions

The study only be will cover two designated hospitals in England. We will identify a list of patients who underwent treatment of femur fractures with antegrade nail (nail introduced from the hip) and

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients having received the Antegrade Femoral Nail for temporary stabilization and fixation of femoral fractures and osteotomies or patients having received the Retrograde Femoral Nail for temporary stabilization and fixation of femoral fractures.

Exclusion criteria

Exclusion criteria: 1. Off-label use 2. Infection in bone or surrounding structures prior to surgery 3. A medullary canal obliterated by a previous fracture or tumor 4. Bone shaft having excessive bow or deformity 5. Lack of bone substance or bone quality, which makes stable seating of the implant impossible 6. All concomitant diseases that can impair the functioning and success of the implant 7. Insufficient blood circulation (peripheral vascular disease) 8. Skeletally immature patients (patients who have an open physis) 9. Patients who are registered in the national data opt-out

Design outcomes

Primary

Measure	Time frame
Time to fracture union is measured using radiographic assessment of complete healing on X-rays at clinical reviews	—

Secondary

Measure	Time frame
1. Occurrence of adverse events is measured using clinician-reported data from medical records at any time until patient discharge 2. Implant-related adverse events are measured using clinician assessment of causality from medical records at any time until patient discharge 3. Hip function is measured using the Oxford Hip Score questionnaire during the follow up call 4. Knee function is measured using the Oxford Knee Score questionnaire during the follow up call 5. Residual pain is measured using the Visual Analogue Scale during the follow up call	—

Measure

Time frame

1. Occurrence of adverse events is measured using clinician-reported data from medical records at any time until patient discharge 2. Implant-related adverse events are measured using clinician assessment of causality from medical records at any time until patient discharge 3. Hip function is measured using the Oxford Hip Score questionnaire during the follow up call 4. Knee function is measured using the Oxford Knee Score questionnaire during the follow up call 5. Residual pain is measured using the Visual Analogue Scale during the follow up call

—

Countries

England, United Kingdom

Contacts

Public ContactRaman Thakur

raman.thakur@nhs.net+44 7865334334

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026