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

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

Study Overview

• Status: Completed
• Conditions: Intertrochanteric Fractures
• Intervention / Treatment: Device: Dynamic Hip Screw with HA-coating (Hiploc); Device: Dynamic Hip Screw without coating (Hiploc)

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HA-coated; Hydroxyapatite coating on Screw thread of DHS	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
ACTIVE_COMPARATOR: NON-coated; No coating on Screw thread of DHS	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Radiological measurements	TAD AP+LAT, fracture reposition AP+LAT (mm)	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	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	Preoperative
Clinical outcomes - Leg Lengths difference	Leg Length difference in cm at 6 months follow-up indicate fracture impaction	6 months
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Hvidovre University Hospital; Hospitalsenheden Vest

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2008
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): February 1, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (ACTUAL): January 10, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Stable Fractures (Evans I, II, IV)
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: H-KF-298036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not possible due til GDPR restrictions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No