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

NCT05677061 | Completed DMC

• 1 other identifier: H-KF-298036
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Intertrochanteric Fractures

Keywords

Stable Fractures (Evans I, II, IV)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Lag screw migration measured as translations in mm

  6 months PO

• Lag screw migration measured as rotations in degrees

  6 months PO

• Radiological measurements

  6 months

• Clinical outcomes - HHS

  6 months PO

• Clinical outcomes - NMS

  Preoperative

Study Arms (2)

HA-coated

EXPERIMENTAL

Hydroxyapatite coating on Screw thread of DHS

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

NON-coated

ACTIVE COMPARATOR

No coating on Screw thread of DHS

Device: Dynamic Hip Screw without coating (Hiploc)

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

HA-coated

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

NON-coated

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable intertrochanteric femoral fractures (Evans I, II, IV)
• able to speak Danish
• able to complete the postoperative controls
• written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Hospitalsenheden Vest: collaborator
• Hvidovre University Hospital: collaborator

Related Publications (1)

• Krogh AC, Thillemann JK, Hansen TB, Holck K, Kristensen MT, Palm H, Stilling M. No effect of hydroxyapatite-coated sliding hip screw threads on screw migration in the femoral head/neck of pertrochanteric fractures: a randomized controlled trial using radiostereometric analysis. J Orthop Surg Res. 2023 Sep 14;18(1):686. doi: 10.1186/s13018-023-04170-0.

  PMID: 37710269 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient and Assessor blinded randomized controlled trial

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 10, 2023
• Study Start: April 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: February 1, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share