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

Primary Purpose

Intertrochanteric Fractures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic Hip Screw with HA-coating (Hiploc)
Dynamic Hip Screw without coating (Hiploc)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intertrochanteric Fractures focused on measuring Stable Fractures (Evans I, II, IV)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HA-coated

    NON-coated

    Arm Description

    Hydroxyapatite coating on Screw thread of DHS

    No coating on Screw thread of DHS

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    Radiological measurements
    TAD AP+LAT, fracture reposition AP+LAT (mm)
    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
    Clinical outcomes - NMS
    New Mobility Score measured on a scale from 0 (no mobility function) to 9 (full independent mobility function) preoperative
    Clinical outcomes - Leg Lengths difference
    Leg Length difference in cm at 6 months follow-up indicate fracture impaction
    Clinical outcomes - TUG test
    Timed Up and Go Test (TUG) at 6 months follow-up (a score less than 20 seconds indicate mobility independence)

    Full Information

    First Posted
    December 7, 2022
    Last Updated
    February 8, 2023
    Sponsor
    University of Aarhus
    Collaborators
    Hospitalsenheden Vest, Hvidovre University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05677061
    Brief Title
    Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
    Official Title
    Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (Actual)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    February 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Hospitalsenheden Vest, Hvidovre University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intertrochanteric Fractures
    Keywords
    Stable Fractures (Evans I, II, IV)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patient and Assessor blinded randomized controlled trial
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HA-coated
    Arm Type
    Experimental
    Arm Description
    Hydroxyapatite coating on Screw thread of DHS
    Arm Title
    NON-coated
    Arm Type
    Active Comparator
    Arm Description
    No coating on Screw thread of DHS
    Intervention Type
    Device
    Intervention Name(s)
    Dynamic Hip Screw with HA-coating (Hiploc)
    Intervention Description
    During surgery for pertrochanteric hip fracture a lag screw with hydroxyapatite coating on the screw thread was used to fix the fracture
    Intervention Type
    Device
    Intervention Name(s)
    Dynamic Hip Screw without coating (Hiploc)
    Intervention Description
    During surgery for pertrochanteric hip fracture a lag screw with no coating on the screw thread was used to fix the fracture
    Primary Outcome Measure Information:
    Title
    Lag Screw migration measured as y-translation (mm)
    Description
    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 Outcome Measure Information:
    Title
    Lag screw migration measured as translations in mm
    Description
    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
    Title
    Lag screw migration measured as rotations in degrees
    Description
    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
    Title
    Radiological measurements
    Description
    TAD AP+LAT, fracture reposition AP+LAT (mm)
    Time Frame
    6 months
    Title
    Clinical outcomes - HHS
    Description
    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
    Title
    Clinical outcomes - NMS
    Description
    New Mobility Score measured on a scale from 0 (no mobility function) to 9 (full independent mobility function) preoperative
    Time Frame
    Preoperative
    Title
    Clinical outcomes - Leg Lengths difference
    Description
    Leg Length difference in cm at 6 months follow-up indicate fracture impaction
    Time Frame
    6 months
    Title
    Clinical outcomes - TUG test
    Description
    Timed Up and Go Test (TUG) at 6 months follow-up (a score less than 20 seconds indicate mobility independence)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Not possible due til GDPR restrictions

    Learn more about this trial

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

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