The DLBP is superior compared to the DHS in terms of revision surgery, union rate, avascular necrosis, implant related failure, as well as functional outcome.
ID
Bron
Verkorte titel
Aandoening
Displaced, femoral neck fractures, DLBP, DHS
Gedisloceerd, femurhalsfractuur, DLBP, DHS
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Rationale:
The Dynamic Locking Blade Plate (DLBP) for fixating displaced femoral neck fractures (FNF) was recently introduced and has been well received. Although the results of this implant in young patients are promising, the DLBP has not yet been compared to a gold standard treatment such as the Dynamic Hip Screw (DHS) in a randomized controlled trial.
Objective: The aim of this study is to compare the clinical outcome of displaced FNF treated with internal fixation by means of the DLBP or the DHS in patients up to 65 years of age. We hypothesize that the DLBP is superior compared to the DHS in terms of revision surgery, union rate, avascular necrosis, implant related failure, as well as functional outcome.
Study design: A multicentre randomized controlled trial.
Study population: Patients of 18-65 years with a displaced FNF
Intervention: One group will be treated with the DLBP. The other group will be treated with DHS (control group).
Main study parameters/endpoints: 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.
Doel van het onderzoek
The DLBP is superior compared to the DHS in terms of revision surgery, union rate, avascular necrosis, implant related failure, as well as functional outcome.
Onderzoeksopzet
Questionairs (iHot12-NL, EQ5D5L, cost related questionair), X rays.
Measurement points. 6 weeks, 3 months, 6 months, 1 year, 2 years.
Onderzoeksproduct en/of interventie
One group will be treated with the DLBP. The other group will be treated with DHS (control group).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 18- 65 years
• Displaced FNF (Garden type III or IV)
• Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7300 |
| NTR-old | NTR7509 |
| Ander register | NL63529.075.18 : METC Isala Zwolle 180428 |