A Prospective Clinical Study On A Total Hip Resurfacing System

NCT ID: NCT00603395

Last Updated: 2014-05-16

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

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2014-05-31

Brief Summary

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This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Detailed Description

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Conditions

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Arthritis Avascular Necrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ReCap

ReCap Total Hip Resurfacing System

Group Type OTHER

ReCap Total Hip Resurfacing System

Intervention Type DEVICE

This is a hip resurfacing system.

Interventions

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ReCap Total Hip Resurfacing System

This is a hip resurfacing system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:

* Osteoarthritis
* Avascular necrosis
* Traumatic arthritis
* Legg Perthes
* Rheumatoid arthritis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Anna Ziekenhuis, Geldrop, Netherlands

OTHER

Sponsor Role lead

Responsible Party

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Walter van der Weegen

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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H J Hoekstra, MD

Role: PRINCIPAL_INVESTIGATOR

St. Anna hospital, Geldrop

T Sybesma, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Anna hospital, Geldrop

Locations

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Knowledge Center for Orthopedic Surgery, St. Anna hospital

Geldrop, , Netherlands

Site Status

Countries

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Netherlands

References

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van der Weegen W, Hoekstra HJ, Sijbesma T, Austen S, Poolman RW. Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system. BMC Musculoskelet Disord. 2012 Dec 13;13:247. doi: 10.1186/1471-2474-13-247.

Reference Type DERIVED
PMID: 23234268 (View on PubMed)

Other Identifiers

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EU-6

Identifier Type: -

Identifier Source: org_study_id

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