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Dynamic Locking Blade Plate (DLBP) versus Dynamic Hip Screw (DHS) voor gedisloceerde femurhals fracturen bij patiënten van 65 jaar en jonger. Een multicenter gerandomiseerd onderzoek.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25678
Enrollment
266
Registered
2018-09-25
Start date
2018-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Displaced, femoral neck fractures, DLBP, DHS Gedisloceerd, femurhalsfractuur, DLBP, DHS

Interventions

One group will be treated with the DLBP. The other group will be treated with DHS (control group).

Sponsors

Deventer Ziekenhuis
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 18- 65 years • Displaced FNF (Garden type III or IV) • Written informed consent

Exclusion criteria

Exclusion criteria: • 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
The main study parameter is the incidence of revision surgery within one year, due to either non-union, avascular necrosis (AVN) or cut out of the implant.

Secondary

MeasureTime frame
Incidence of avascular necrosis of the femoral head Incidence of non-union of the fracture Incidence of implant related complications Post-operative complications Rate of elective implant removal after union Functional outcome Operation time Costs of both interventions Health related quality of life after the intervention

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)