Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral Stem

NCT ID: NCT01614028

Last Updated: 2013-04-09

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

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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This study aims to investigate short-term outcomes following the use of two femoral stems used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.

Detailed Description

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Conditions

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Total Hip Arthroplasty

Study Groups

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Total Hip Arthroplasty using Fitmore femoral stem

Group Type ACTIVE_COMPARATOR

Total Hip Arthoplasty

Intervention Type PROCEDURE

Total Hip Arthroplasty using M/L Taper Femoral stem

Group Type ACTIVE_COMPARATOR

Total Hip Arthoplasty

Intervention Type PROCEDURE

Interventions

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Total Hip Arthoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient signed an IRB, study specific informed patient consent.
* Patient is a male or non-pregnant female age 18 years or older at the time of study device implantation.
* Patient has primary diagnosis of non-inflammatory degenerative joint disease.
* Patient is a candidate for primary cementless total hip replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

* Patient has a Body Mass Index (BMI) \> 40 Kg/m2.
* Patient has an active or suspected infection at the time of device implantation.
* Patient is immunologically suppressed.
* Patient requires revision surgery of a previously implanted total hip replacement.
* Patient has a known sensitivity to device materials.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Institute at AtlantiCare

Egg Harbor, New Jersey, United States

Site Status RECRUITING

Rothman Institute at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Anne Marie Madden, CCRP

Role: primary

609-407-6446

Tiffany Morrison, MS, CCRP

Role: primary

267-339-7818

Other Identifiers

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JP2012-01

Identifier Type: -

Identifier Source: org_study_id

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