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Completed

NCT Number: NCT05677061

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

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Key information

Conditions

Intertrochanteric Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Lag Screw migration measured as y-translation (mm)

    Time frame: 6 months PO

    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 outcomes

  1. Lag screw migration measured as translations in mm

    Time frame: 6 months PO

    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

  2. Lag screw migration measured as rotations in degrees

    Time frame: 6 months PO

    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

  3. Radiological measurements

    Time frame: 6 months

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

  4. Clinical outcomes - HHS

    Time frame: 6 months PO

    Change in Harris Hip Score (HHS) measured as a scale from 0 (worst) to 100 (best) from pre-operative til 6 months postoperative

  5. Clinical outcomes - NMS

    Time frame: Preoperative

    New Mobility Score measured on a scale from 0 (no mobility function) to 9 (full independent mobility function) preoperative

  6. Clinical outcomes - Leg Lengths difference

    Time frame: 6 months

    Leg Length difference in cm at 6 months follow-up indicate fracture impaction

  7. Clinical outcomes - TUG test

    Time frame: 6 months

    Timed Up and Go Test (TUG) at 6 months follow-up (a score less than 20 seconds indicate mobility independence)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Hospitalsenheden Vest
  • Hvidovre University Hospital

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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