Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
NCT ID: NCT05677061
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2008-04-30
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HA-coated
Hydroxyapatite coating on Screw thread of DHS
Dynamic Hip Screw with HA-coating (Hiploc)
During surgery for pertrochanteric hip fracture a lag screw with hydroxyapatite coating on the screw thread was used to fix the fracture
NON-coated
No coating on Screw thread of DHS
Dynamic Hip Screw without coating (Hiploc)
During surgery for pertrochanteric hip fracture a lag screw with no coating on the screw thread was used to fix the fracture
Interventions
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Dynamic Hip Screw with HA-coating (Hiploc)
During surgery for pertrochanteric hip fracture a lag screw with hydroxyapatite coating on the screw thread was used to fix the fracture
Dynamic Hip Screw without coating (Hiploc)
During surgery for pertrochanteric hip fracture a lag screw with no coating on the screw thread was used to fix the fracture
Eligibility Criteria
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Inclusion Criteria
* able to speak Danish
* able to complete the postoperative controls
* written consent
Exclusion Criteria
* were breastfeeding
* pregnant
* terminal disease
* in need of open fracture reduction
* in need of DHS plate with an angle different from 135 degrees
* insertion of fewer than 3 tantalum beads in the femoral head (for RSA)
* TAD \>20mm in two dimensions in the first postoperative x-ray
* fracture displacement \>20mm in two dimensions in the first postoperative x-ray
50 Years
ALL
No
Sponsors
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Hospitalsenheden Vest
OTHER
Hvidovre University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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References
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Krogh AC, Thillemann JK, Hansen TB, Holck K, Kristensen MT, Palm H, Stilling M. No effect of hydroxyapatite-coated sliding hip screw threads on screw migration in the femoral head/neck of pertrochanteric fractures: a randomized controlled trial using radiostereometric analysis. J Orthop Surg Res. 2023 Sep 14;18(1):686. doi: 10.1186/s13018-023-04170-0.
Other Identifiers
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H-KF-298036
Identifier Type: -
Identifier Source: org_study_id
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