Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Study Overview
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Brief Summary
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Evaluated whether HA coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures

Detailed Description
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Randomised study to determine the effect of HA coating on the stability of dynamic Hip screws used to stabilize femoral neck fractures. Stability of the screw will be determined by RSA measurements. Additionally the fracture stability will be evaluated by RSA measurements.

Official Title
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Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Conditions
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Intertrochanteric Fractures

Intervention / Treatment
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* Device: Dynamic Hip Screw with HA-coating (Hiploc)
* Device: Dynamic Hip Screw without coating (Hiploc)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stable intertrochanteric femoral fractures (Evans I, II, IV) able to speak Danish able to complete the postoperative controls written consent Exclusion Criteria: unable to follow standard hip fracture regime 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient and Assessor blinded randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA-coated<br>Hydroxyapatite coating on Screw thread of DHS | Device: Dynamic Hip Screw with HA-coating (Hiploc)<br>* During surgery for pertrochanteric hip fracture a lag screw with hydroxyapatite coating on the screw thread was used to fix the fracture<br>|
| Active Comparator: NON-coated<br>No coating on Screw thread of DHS | Device: Dynamic Hip Screw without coating (Hiploc)<br>* During surgery for pertrochanteric hip fracture a lag screw with no coating on the screw thread was used to fix the fracture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lag Screw migration measured as y-translation (mm) | Lag screw migration measured as y-translation (mm) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up | 6 months PO | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lag screw migration measured as translations in mm | Lag screw migration measured as translations in mm along the three orthogonal axes (x and z) and rotations in degrees about the three orthogonal axes (x, y and z) in addition to the summed translations (total translation) and summed rotations (total rotation) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up | 6 months PO | 
| Lag screw migration measured as rotations in degrees | Lag screw migration measured as rotations in degrees about the three orthogonal axes (x, y and z) in addition to the summed summed rotations (total rotation) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up | 6 months PO | 
| Radiological measurements | TAD AP+LAT, fracture reposition AP+LAT (mm) | 6 months | 
| Clinical outcomes - HHS | Change in Harris Hip Score (HHS) measured as a scale from 0 (worst) to 100 (best) from pre-operative til 6 months postoperative | 6 months PO | 
| Clinical outcomes - NMS | New Mobility Score measured on a scale from 0 (no mobility function) to 9 (full independent mobility function) preoperative | Preoperative | 
| Clinical outcomes - Leg Lengths difference | Leg Length difference in cm at 6 months follow-up indicate fracture impaction | 6 months | 
| Clinical outcomes - TUG test | Timed Up and Go Test (TUG) at 6 months follow-up (a score less than 20 seconds indicate mobility independence) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stable Fractures (Evans I, II, IV)