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Is there radiological difference between te standard nail and the trochanteric Gammanail for treatment of hip fractures?


- candidate number19396
- NTR NumberNTR4771
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2014
- Secondary IDs13-N-153 13.238
- Public TitleIs there radiological difference between te standard nail and the trochanteric Gammanail for treatment of hip fractures?
- Scientific TitleIs there radiological difference between te standard Gamma nail and the trochanteric Gammanail?
- ACRONYM
- hypothesisThere will be no difference between both nails
- Healt Condition(s) or Problem(s) studiedHip fractures
- Inclusion criteriaPatients with pertrochanteric, subtrochanteric and reversed type subtrochanteric fractures will be included.
- Exclusion criteriaPathological fractures or impending pathological fractures wil be excluded
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2014
- planned closingdate1-mrt-2014
- Target number of participants250
- InterventionsGamma Nail system from Stryker:
* Trochanteric Gamma Nail
* Gamma3 Nail
- Primary outcomeMain outcome parameter is the prevalence of medial pelvic migration of the lag screw of the nails.
* tip apex distance (TAD)
* Parkerís ratio
- Secondary outcomeAnasthesia technique, surgery duration, blood loss, intra- and postoperative complications, postoperative treatment, relevant medical history, drug use, intoxications and death wil be compared.
- TimepointsPeri operative, >7 years follow-up.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Orbis Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsNA
- Brief summaryWe decided to retrospectively compare the results of the Standard Gamma nail and the Trochanteric Gamma nail in our clinic. The goal of this study is to compare the prevalence of medial pelvic migration of the lag screw in the two devices.
- Main changes (audit trail)
- RECORD4-sep-2014 - 27-sep-2014


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