Clinical Observation Study With the SBG Stem

NCT ID: NCT02338661

Last Updated: 2018-05-01

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

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2018-04-24

Brief Summary

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This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.

Detailed Description

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Conditions

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Arthroplasty, Hip Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SBG hip stem

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients requiring the implantation of the SBG hip stem

Exclusion Criteria

* general medical contraindications to surgery
* acute or recent infection of joint
* atrophy or deformation of upper femur
* muscular atrophy or neuromuscular disease
* pathologic fractures
* per- and subtrochanteric fractures
* revision of failed hip endoprosthesis
* hypersensitivity to used materials
* any conditions preventing stable anchoring of the hip prosthesis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew Orthopaedics AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beat Schmid, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Praxis Klinik Gut Buchs

Locations

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Praxis Klinik Gut Buchs

Buchs, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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D8319

Identifier Type: -

Identifier Source: org_study_id

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