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Dynamic Locking Blade Plate (DLBP) versus Dynamic Hip Screw (DHS) for displaced femoral neck fractures in patients 65 years of age and younger. A multicentre randomized controlled trial

Dynamic Locking Blade Plate (DLBP) versus Dynamic Hip Screw (DHS) for displaced femoral neck fractures in patients 65 years of age and younger. A multicentre randomized controlled trial - DEFENDD study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52560
Enrollment
266
Registered
2018-08-31
Start date
2019-10-14
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Femoral neck fracture. Hip fracture

Interventions

One group will be treated with the Dynamic Locking Blade Plate. The other group will be treated with Dynamic Hip screw (control group).

Sponsors

Deventer Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • 18- 65 years • Displaced Femoral Neck Fracture (Garden type III or IV) 14 • Written informed consent

Exclusion criteria

Exclusion criteria: Patients with: • Pathological fracture. • Ipsilateral or contralateral fractures of the lower extremity. • Patients with an Injury Severity Score (ISS) of >=16. • Local infection or inflammation. • Symptomatic arthritis, diagnosed by a rheumatologist. • Symptomatic osteoarthritis or radiographic osteoarthritis grade III or IV. 15 • Previous surgery to the ipsilateral hip. • Inadequate tissue coverage. • Morbid obesity (BMI >= 35). • Patients who are wheelchair-bound. • Patients who were, at the time of trauma, admitted to a nursing home. • Patients who are not mentally competent

Design outcomes

Primary

MeasureTime frame
Incidence of revision surgery after fixation of a displaced FNF treated with DLBP or DHS due to non-union, AVN or cut out of the implant.

Secondary

MeasureTime frame
Incidence of avascular necrosis Incidence of non-union Incidence of implant related complications. Post-operative complications Rate of elective implant removal after union Functional outcome Operation time Costs Health related quality of life.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)