Prospective Clinical Evaluation of Three Prosthesis Re-cap, M2a-Magnum and C2a-taper.

NCT ID: NCT00284674

Last Updated: 2017-03-24

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

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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This evaluation is being conducted to evaluate the performance of thee prosthesis.

Detailed Description

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Conditions

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Patients Undergoing a THR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Hip prosthesis (re-cap, m2a-magnum and C2a-taper)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Good general health of age (ASA I-II)
* DEXA-scanning: lower limit for a 55 years old man
* MRI normal vitality in caput
* Willing to return for follow-up evaluations

Exclusion Criteria

* Subjects displaying any of the following contra-indications shall be excluded from this evaluation:
* Inability to co-operate with and complete the study
* Collum \< 2 cm
* Large cysts in caput
* Mismatch between caput acetabulum
* Caput necrosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Arne Borgwardt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arne Borgwardt, M.D.

Role: STUDY_DIRECTOR

Frederiksberg University Hospital

Locations

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Frederiksberg University Hospital

Copenhagen, Frederiksberg, Denmark

Site Status

Countries

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Denmark

References

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Borgwardt A, Borgwardt L, Zerahn B, Daugaard H, Borgwardt L, Ribel-Madsen S. A Randomized Seven-Year Study on Performance of the Stemmed Metal M2a-Magnum and Ceramic C2a-Taper, and the Resurfacing ReCap Hip Implants. J Arthroplasty. 2018 May;33(5):1412-1420. doi: 10.1016/j.arth.2017.11.061. Epub 2017 Dec 5.

Reference Type DERIVED
PMID: 29276121 (View on PubMed)

Other Identifiers

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KF-01-287.591

Identifier Type: -

Identifier Source: org_study_id

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