Intertrochanteric Fractures
Conditions
Keywords
Stable Fractures (Evans I, II, IV)
Brief summary
Evaluated whether HA coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures
Detailed description
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.
Interventions
DEVICEDynamic 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
DEVICEDynamic 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
Sponsors
Hospitalsenheden Vest
Hvidovre University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Patient and Assessor blinded randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lag Screw migration measured as y-translation (mm) | 6 months PO | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lag screw migration measured as rotations in degrees | 6 months PO | 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 |
| Radiological measurements | 6 months | TAD AP+LAT, fracture reposition AP+LAT (mm) |
| Clinical outcomes - HHS | 6 months PO | Change in Harris Hip Score (HHS) measured as a scale from 0 (worst) to 100 (best) from pre-operative til 6 months postoperative |
| Lag screw migration measured as translations in mm | 6 months PO | 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 |
| Clinical outcomes - Leg Lengths difference | 6 months | Leg Length difference in cm at 6 months follow-up indicate fracture impaction |
| Clinical outcomes - TUG test | 6 months | Timed Up and Go Test (TUG) at 6 months follow-up (a score less than 20 seconds indicate mobility independence) |
| Clinical outcomes - NMS | Preoperative | New Mobility Score measured on a scale from 0 (no mobility function) to 9 (full independent mobility function) preoperative |
Outcome results
None listed