Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-06

Study Completion Date

2017-06-07

Brief Summary

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A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.

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Detailed Description

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The study objective was to evaluate if there was a difference between the femoral position of the last trial rasp and the final implant position of the SL-PLUS™ MIA Ti/HA femoral hip stem. The femoral position of rasp or stem was considered as the height of the implant / rasp in cranio-caudal direction.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Total Hip Arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patient:

* requires primary THA with the SL-PLUS™ MIA Ti/HA femoral hip stem
* is at least 21 years of age at the time of surgery
* is skeletally mature in the PI's judgment
* has consented to participate in the study by signing the EC approved ICF

Exclusion Criteria

Patient:

* requires the use of a ceramic-on-ceramic bearing
* has infections, acute or chronic, local or systemic
* has severe muscle, nerve or vascular diseases that endanger the respective limb
* has lack of bone substance or defective bone quality that jeopardizes the stable seating of the prosthesis
* has any concomitant disease that may jeopardize implant function
* has a known allergy to study device or one or more of its components
* requires a revision surgery and has extensive bone defects
* has diagnosis of an immunosuppressive disorder
* is pregnant

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No