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

NCT ID: NCT05677061

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2023-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Intertrochanteric Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient and Assessor blinded randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HA-coated

Hydroxyapatite coating on Screw thread of DHS

Group Type EXPERIMENTAL

Dynamic Hip Screw with HA-coating (Hiploc)

Intervention Type DEVICE

During surgery for pertrochanteric hip fracture a lag screw with hydroxyapatite coating on the screw thread was used to fix the fracture

NON-coated

No coating on Screw thread of DHS

Group Type ACTIVE_COMPARATOR

Dynamic Hip Screw without coating (Hiploc)

Intervention Type DEVICE

During surgery for pertrochanteric hip fracture a lag screw with no coating on the screw thread was used to fix the fracture

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospitalsenheden Vest

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 37710269 (View on PubMed)

Other Identifiers

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H-KF-298036

Identifier Type: -

Identifier Source: org_study_id

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