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

Not Applicable

Completed

• Conditions: Intertrochanteric Fractures
• Interventions: Device: Dynamic Hip Screw without coating (Hiploc); Device: Dynamic Hip Screw with HA-coating (Hiploc)

• Registration Number: NCT05677061
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2013-08
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-10
• Status Verified: 2023-02
• Study Completion: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NON-coated	Dynamic Hip Screw without coating (Hiploc)	No coating on Screw thread of DHS
HA-coated	Dynamic Hip Screw with HA-coating (Hiploc)	Hydroxyapatite coating on Screw thread of DHS

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical outcomes - NMS	Preoperative	New Mobility Score measured on a scale from 0 (no mobility function) to 9 (full independent mobility function) preoperative
Clinical outcomes - Leg Lengths difference	6 months	Leg Length difference in cm at 6 months follow-up indicate fracture impaction
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)
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 - 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
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)