Mini Stem DEXA (Dual Energy X-ray Absorptiometry)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-14

Study Completion Date

2016-04-18

Brief Summary

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The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

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Detailed Description

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The purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.

Conditions

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Osteoarthritis, Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient has hip disease that requires a total hip arthroplasty.
* Patient is willing to consent to participate in the study.
* Patient plans to be available for the study duration.
* Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.

Exclusion Criteria

* Patient known to have insufficient bone stock.
* Patient has had major non-arthroscopic surgery to the study hip.
* Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
* Patient has a known sensitivity to materials in the device.

Eligible Sex

ALL

Accepts Healthy Volunteers

No