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| Name | Class |
|---|---|
| Hospitalsenheden Vest | OTHER |
| Hvidovre University Hospital | OTHER |
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Evaluated whether HA coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA-coated | Experimental | Hydroxyapatite coating on Screw thread of DHS |
|
| NON-coated | Active Comparator | No coating on Screw thread of DHS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Hip Screw with HA-coating (Hiploc) | Device | During surgery for pertrochanteric hip fracture a lag screw with hydroxyapatite coating on the screw thread was used to fix the fracture |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37710269 | Derived | 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. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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Patient and Assessor blinded randomized controlled trial
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| Dynamic Hip Screw without coating (Hiploc) | Device | During surgery for pertrochanteric hip fracture a lag screw with no coating on the screw thread was used to fix the fracture |
|
| 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 |
| D007869 |
| Leg Injuries |