A Clinical Investigation of the Balance® Microplasty™ Hip System

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

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System.

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Detailed Description

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Conditions

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Osteoarthritis, Hip Rheumatoid Arthritis Avascular Necrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Balance® Microplasty™ Hip System

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis.
* Correction of functional deformity.
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
* Revision of previously failed femoral head resurfacing component

Exclusion Criteria

Absolute contraindications include:

* infection,
* sepsis,
* osteomyelitis.

Relative contraindications include:

* uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* osteoporosis,
* metabolic disorders which may impair bone formation,
* osteomalacia,
* distant foci of infections which may spread to the implant site,
* rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
* vascular insufficiency, muscular atrophy, or neuromuscular disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No