Clinical Observation Study With the SBG Stem

April 30, 2018 updated by: Smith & Nephew Orthopaedics AG
This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buchs, Switzerland
        • Praxis Klinik Gut Buchs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score
Time Frame: Baseline and 10 years post surgery
Change in Harris Hip Score from Baseline to 10 years post surgery. The Harris Hip Score scales from 0-100 with higher values representing a better score.
Baseline and 10 years post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of position of hip stem
Time Frame: Baseline and 10 years post surgery
Change in hip stem position from Baseline to 10 years post surgery.
Baseline and 10 years post surgery
Radiographic Analysis: classification of osseointegration of hip stem
Time Frame: 10 years post surgery
10 years post surgery
Radiographic Analysis: radiolucent lines around hip stem
Time Frame: 10 years post surgery
Radiographic measurements will be taken of linear radiolucencies. Radiolucent lines will be measured in mm.
10 years post surgery
Radiographic Analysis: number of participants with femoral osteolysis around hip stem
Time Frame: 10 years post surgery
10 years post surgery
Radiographic Analysis: bone atrophy around hip stem
Time Frame: 10 years post surgery
Radiographic measurements will be taken of bone atrophy. Bone atrophy will be measured in mm.
10 years post surgery
Radiographic Analysis: bone hypertrophy around hip stem
Time Frame: 10 years post surgery
Radiographic measurements will be taken of bone hypertrophy. Bone hypertrophy will be measured in mm.
10 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Beat Schmid, Dr. med., Praxis Klinik Gut Buchs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

April 24, 2018

Study Completion (Actual)

April 24, 2018

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • D8319

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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