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

University of Aarhus

Status: Completed

Conditions: Intertrochanteric Fractures

Treatments: Device: Dynamic Hip Screw without coating (Hiploc); Device: Dynamic Hip Screw with HA-coating (Hiploc)

Study type: Interventional

Funder types: Other

Identifiers

NCT05677061

H-KF-298036

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups

HA-coated

Experimental group

Description:

Hydroxyapatite coating on Screw thread of DHS

Treatment:

Device: Dynamic Hip Screw with HA-coating (Hiploc)

NON-coated

Active Comparator group

Description:

No coating on Screw thread of DHS

Treatment:

Device: Dynamic Hip Screw without coating (Hiploc)