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

NCT ID: NCT00756431

Last Updated: 2017-06-19

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-06-30

Brief Summary

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Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures

Detailed Description

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Randomised study to determine the effect of HA coating on the stability of lag screws used to reduce femoral neck fractures. Stability of the screw will be determined by RSA measurements. The effect of the HA coating on bone remodeling will be determined by DEXA measurements

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Screw without HA Coating (Hiploc)

Group Type ACTIVE_COMPARATOR

Hip Fracture reduction Screw without HA Coating (Hiploc)

Intervention Type DEVICE

Hip Fracture reduction Screw without HA Coating (Hiploc)

Screw with HA Coating (Hiploc)

Group Type EXPERIMENTAL

Hip Fracture reduction Screw with HA Coating (Hiploc)

Intervention Type DEVICE

Hip Fracture reduction Screw with HA Coating (Hiploc)

Interventions

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Hip Fracture reduction Screw without HA Coating (Hiploc)

Hip Fracture reduction Screw without HA Coating (Hiploc)

Intervention Type DEVICE

Hip Fracture reduction Screw with HA Coating (Hiploc)

Hip Fracture reduction Screw with HA Coating (Hiploc)

Intervention Type DEVICE

Other Intervention Names

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Hiploc Hiploc

Eligibility Criteria

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Inclusion Criteria

* Patients with trochanteric femoral fractures
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Biomet U.K. Ltd.

INDUSTRY

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hendrik Palm, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre Univ. Hospital

Other Identifiers

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BMET UK 06

Identifier Type: -

Identifier Source: org_study_id

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