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

University of Aarhus37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Intertrochanteric Fractures

Interventions

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

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 6 months PO

Secondary Outcomes

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

Time frame: 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

Time frame: 6 months PO

Radiological measurements

TAD AP+LAT, fracture reposition AP+LAT (mm)

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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