Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem

NCT ID: NCT01566916

Last Updated: 2014-02-12

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 prospective, randomized study will study the 2 year survivorship and short term outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two surgical approaches. The surgical approaches being studied are direct anterior and anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will be compared. Subjects will be randomized to surgical approach and followed for a period of two years.

Detailed Description

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Conditions

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Total Hip Arthroplasty

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Total Hip Arthroplasty performed via direct anterior approach

Group Type ACTIVE_COMPARATOR

Total Hip Arthroplasty

Intervention Type PROCEDURE

Total Hip Arthroplasty using anterolateral approach

Group Type ACTIVE_COMPARATOR

Total Hip Arthroplasty

Intervention Type PROCEDURE

Interventions

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Total Hip Arthroplasty

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 21 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

21 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

Egg Harbor, New Jersey, United States

Site Status

Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Tiffany Morrison, MS, CCRP

Role: CONTACT

267-339-7818

Other Identifiers

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RIFJPAR 12-01

Identifier Type: -

Identifier Source: org_study_id

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