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

Intertrochanteric Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05677061
• Other study ID #: H-KF-298036
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: February 2023

Study information

• Verified date: February 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2023
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures

Intervention

Device:
• Dynamic 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
• Dynamic 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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Hospitalsenheden Vest, Hvidovre University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Radiological measurements	TAD AP+LAT, fracture reposition AP+LAT (mm)	6 months
Secondary	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
Secondary	Clinical outcomes - NMS	New Mobility Score measured on a scale from 0 (no mobility function) to 9 (full independent mobility function) preoperative	Preoperative
Secondary	Clinical outcomes - Leg Lengths difference	Leg Length difference in cm at 6 months follow-up indicate fracture impaction	6 months
Secondary	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