Greenville Memorial Hosptial
Greenville, South Carolina, 29605, United States
NCT Number: NCT05094791
Intertrochanteric fractures are commonly stabilized using an intramedullary nail with a lag screw that enters the lateral cortex of the femur. This lag screw commonly protrudes during the healing process and may cause implant related pain. This study will help determine if implant related pain is different depending to the lag screw design.
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Notify Me22 year and older
All sexes
Observational
Greenville, South Carolina, 29605, United States
This study compares cephalomedullary fixation of intertrochanteric femur fractures using the Arthrex Hip Nail System with a telescoping lag screw compared to the Zimmer Natural Nail and the Smith and Nephew InterTan. This pilot study will evaluate radiographic outcomes and lateral sided hip pain related to different lag screw designs used for patients with intertrochanteric femur fractures by comparing outcomes of patients receiving 3 different lag screws The primary objective of this study is to compare pain at the level of the lag screw of patients with collapsible lag screws compared to patient who received a standard lag screw using a numeric rating scale on a 0-100 scale.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw
Other names: Arthrex Hip Nail
Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw
Other names: Zimmer Natural Nail
Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw
Other names: Smith and Nephew TRIGEN INTERTAN
Time frame: 6 weeks
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Time frame: 12 weeks
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Time frame: 21 weeks
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Time frame: 52 weeks
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Time frame: 52 weeks
Change in the lateralization of the lag screw measured in mm
Time frame: 52 weeks
Incidence of patients requiring injections at the location of the lag screw due to pain
Time frame: 52 weeks
Reoperations to the location in the intertrochanteric fractue
Prisma Health-Upstate
Other
Acronym: LIMIT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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