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| Name | Class |
|---|---|
| Arthrex, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telescoping Lag Screw | Intertrochanteric fractures treated with Arthrex Hip Nail with Telescoping Screw |
| |
| Standard lag Screw | Intertrochanteric fractures treated with Zimmer Natural Nail Cephalomedullary Nail |
| |
| Standard lag screw with addition of worm screw | Intertrochanteric fractures treated with Smith and Nephew TRIGEN INTERTAN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telescoping Lag Screw | Device | Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain at lag screw | Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100) | 6 weeks |
| Pain at lag screw | Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100) | 12 weeks |
| Pain at lag screw | Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100) | 21 weeks |
| Pain at lag screw | Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic lateralization of lag screw | Change in the lateralization of the lag screw measured in mm | 52 weeks |
| Incidence of lag screw injections | Incidence of patients requiring injections at the location of the lag screw due to pain |
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Inclusion Criteria:
Exclusion Criteria:
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Patients sustaining an intertrochantic hip fracture
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| Name | Affiliation | Role |
|---|---|---|
| John D Adams, MD | Prisma Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenville Memorial Hosptial | Greenville | South Carolina | 29605 | United States |
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| Standard lag Screw | Device | Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw |
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| Standard lag screw with addition of worm screw | Device | Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw |
|
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| 52 weeks |
| Reoperation rate | Reoperations to the location in the intertrochanteric fractue | 52 weeks |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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