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RSA study on trochanteric fractures: DHS versus gamma-nail.


- candidate number7771
- NTR NumberNTR2221
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2010
- Secondary IDsp09.246 CME
- Public TitleRSA study on trochanteric fractures: DHS versus gamma-nail.
- Scientific TitleFixation device related rotational and translational influences in trochanteric femoral fractures: A radio stereometric analysis of the DHS versus the gamma-nail.
- ACRONYM
- hypothesisSeveral fixation devices have been developed for treatment of proximal femur fractures. Still, treatment of these fractures suffers from relatively high complication rates. For treatment of trochanteric fractures extramedullary sliding hip screw devices (e.g. DHS) and intramedullary nail fixations (e.g. Gamma-nail) are commonly used. Both implants are related to complications like cut-out of the femoral head screw, nonunion and malunion. Some of these complications may be accounted for by the induction of rotation of the femoral head-trochanter fragment.
Objective: To determine the amount of in fracture micromotion (i.e. translation and rotation) in trochanteric femoral fractures, related to type of used implant: a DHS or a gamma-nail. The secondary objective is to relate the micromotion to bone density, and the position of the femoral head screw.
- Healt Condition(s) or Problem(s) studiedTreatment, Femoral fractures
- Inclusion criteria1. Aged over 60;
2. AO31-A2 type trochanteric fracture;
3. Informed consent.
- Exclusion criteria1. Aged under 60;
2. AO31-A1 or A3 type trochanteric fracture;
3. No informed consent;
4. Severe arthritis of the involved hip;
5. Reumatoid arthritis;
6. Pathological fracture;
7. Pre-existent immobility.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2010
- planned closingdate1-mrt-2011
- Target number of participants60
- InterventionsSixty patients, age >60 years, with an AO31-A2 type trochanteric fracture will be randomly allocated to treatment with either DHS or Gamma-nail.

Intervention: Micromotion across the fracture site (translation and rotation) determines stability of the performed osteosynthesis. Only if this micromotion is determined threedimensionally, potential failure mechanisms can be analysed. Radiostereometric analysis (RSA) will be used to measure micromotion along the three orthogonal axes of the fracture fragments. RSA radiographs are obtained postoperatively, on the first day, after 6 weeks, 4 months and one year. A 7-region dexa scan of both the fractured and non-fractured proximal femur and lumbar spine will be acquired within 6 weeks after fracture fixation.
- Primary outcomeMain study parameters/endpoints:
Parameters: Demographical data, co-morbidity, rotation and translation as determined on RSA radiographs, type of implant: intra-, or extra-medullary, position of the femoral head screw, bone density and adverse events.

Primary endpoint: Rotation and translation as determined on RSA radiographs in relation to type of implant used: intra-, or extra-medullary.
- Secondary outcomeSecondary endpoints: Micromotion in relation to the position of the femoral head screw and bone density. Local adverse events (cut-out, implant failure).
- TimepointsRSA radiographs are obtained postoperatively, on the first day, after 6 weeks, 4 months and one year. A 7-region dexa scan of both the fractured and non-fractured proximal femur and lumbar spine will be acquired within 6 weeks after fracture fixation.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. I.B. Schipper
- CONTACT for SCIENTIFIC QUERIESMD. D. Embden, van
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryRationale:
Several fixation devices have been developed for treatment of proximal femur fractures. Still, treatment of these fractures suffers from relatively high complication rates. For treatment of trochanteric fractures extramedullary sliding hip screw devices (e.g. DHS) and intramedullary nail fixations (e.g. Gamma-nail) are commonly used. Both implants are related to complications like cut-out of the femoral head screw, nonunion and malunion. Some of these complications may be accounted for by the induction of rotation of the femoral head-trochanter fragment.

Objective:
To determine the amount of in fracture micromotion (i.e. translation and rotation) in trochanteric femoral fractures, related to type of used implant: a DHS or a gamma-nail. The secondary objective is to relate the micromotion to bone density, and the position of the femoral head screw.

Study design and Study population:
Sixty patients, age >60 years, with an AO31-A2 type trochanteric fracture will be randomly allocated to treatment with either DHS or Gamma-nail.

Intervention:
Micromotion across the fracture site (translation and rotation) determines stability of the performed osteosynthesis. Only if this micromotion is determined threedimensionally, potential failure mechanisms can be analysed. Radiostereometric analysis (RSA) will be used to measure micromotion along the three orthogonal axes of the fracture fragments. RSA radiographs are obtained postoperatively, on the first day, after 6 weeks, 4 months and one year. A 7-region dexa scan of both the fractured and non-fractured proximal femur and lumbar spine will be acquired within 6 weeks after fracture fixation.

Main study parameters/endpoints:
Parameters: Demographical data, co-morbidity, rotation and translation as determined on RSA radiographs, type of implant: intra-, or extra-medullary, position of the femoral head screw, bone density and adverse events.
Primary endpoint: Rotation and translation as determined on RSA radiographs in relation to type of implant used: intra-, or extra-medullary.
Secondary endpoints: Micromotion in relation to the position of the femoral head screw and bone density. Local adverse events (cut-out, implant failure).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The tantalum beads used with RSA are non-toxic and are not known to be associated to any burden or risk. Radiation risks (280 ÁSv in conventional hip X-rays versus 150 ÁSv in RSA X-rays) are minimal and should be regarded in the context of the generally high age of this patient population. All patients will be invited to a normal postoperative follow up protocol. Patients might benefit from the extended (radiological) examination during their follow up. A dexa scan is associated with 40 ÁSv. In patients that are diagnosed with osteoporosis, treatment will be started.
- Main changes (audit trail)
- RECORD16-feb-2010 - 5-mrt-2010


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