We expect an increased bone mineral density in the calcar region compared to the other ROI’s. Furthermore, we expect early detection of decreased mineral density of the femoral head in patients developing osteonecrosis of the femoral head.
ID
Bron
Verkorte titel
Aandoening
Hip fracture
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Changes in bone mineral density measured with Dual energy X-ray Absorptiometry in several regions of interest in the hip treated with a dynamic hip screw as a treatment for an intracapsular femoral neck fracture.
Achtergrond van het onderzoek
Rationale: Intracapsular femoral neck fractures are common and are often treated with a dynamic hip screw in relatively young patients (<60 years). Complications as a cut-out or osteonecrosis of the femoral head after treatment with a dynamic hip screw still occur. The reason for these complications are possibly caused by bone remodeling around the dynamic hip screw and within the femoral head. Therefore, early detection of changes in bone density is needed. Literature regarding bone remodeling around the dynamic hip screw is scarce.
Objective: In this study we will monitor changes in bone mineral densities after intracapsular femoral neck fractures treated with a dynamic hip screw.
Study design: In this exploratory prospective study, we will include 25 patients with an intracapsular femoral neck fracture treated with a dynamic hip screw.
Study population: The study cohort consists of 25 patients who are treated with a dynamic hip screw after an intracapsular femoral neck fracture.
Intervention: Standardized measurements with Dual energy X-ray Absorptiometry will be done direct postoperatively and after 1, 3, 6 and 12 months postoperatively.
Main study parameters/endpoints: Changes in bone mineral density measured with Dual energy X-ray Absorptiometry in several regions of interest in the hip treated with a dynamic hip screw as a treatment for an intracapsular femoral neck fracture.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Four extra Dual energy X-ray Absorptiometry’s will be performed. Visits to the hospital are needed. A disadvantage is the extra, limited, radiation.
Doel van het onderzoek
We expect an increased bone mineral density in the calcar region compared to the other ROI’s. Furthermore, we expect early detection of decreased mineral density of the femoral head in patients developing osteonecrosis of the femoral head.
Onderzoeksopzet
15/07/2020: start inclusion
01/01/2021: end inclusion
01/01/2022: end follow-up
01/04/2022: submission article
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients are eligible to participate if they are diagnosed with an intracapsular femoral neck fracture and are treated with a dynamic hip screw.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients are excluded from this study if the affected hip has a history of osteonecrosis of the femoral head, Perthes, osteoarthritis (Kellgren and Lawrence score III or IV) or a previous operation. Furthermore, patients that did not fully weight-bear the operated hip preoperatively will be excluded too.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8649 |
| Ander register | METC Rijnstate : 2020-1641 |