- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02338661
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
Conditions
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.
Sponsor
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.
Clinical Trials on Arthroplasty, Hip Replacement
-
Fondazione Don Carlo Gnocchi OnlusCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipItaly
-
Bornholms RegionskommuneCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipDenmark
-
Campus Bio-Medico UniversityRecruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipItaly
-
SCRI Development Innovations, LLCWithdrawnArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
-
Sunnybrook Health Sciences CentreActive, not recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipCanada
-
University of British ColumbiaThe Arthritis Society, Canada; Centre for Aging SMART; Centre for Advancing Health...Not yet recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipCanada
-
University Hospital, Strasbourg, FranceRecruitingArthroplasty, Hip Replacement | Arthroplasty, Knee ReplacementFrance
-
Henry Ford Health SystemConsumer Sleep SolutionsNot yet recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
-
Haute Ecole de Santé VaudCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipSwitzerland
-
The Cleveland ClinicZimmer Biomet; Accelero Health Partners, LLCCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
Clinical Trials on SBG hip stem
-
DePuy OrthopaedicsTerminatedOsteoarthritis | Rheumatoid Arthritis | Avascular Necrosis | Post-traumatic Arthritis | Acute FractureUnited States
-
Canadian Radiostereometric Analysis NetworkCompleted
-
Zimmer BiometBiomet Spain Orthopaedics S.L.Terminated
-
Istituto Ortopedico RizzoliCompleted
-
Association pour le Développement et l'Enseignement...RecruitingOsteoarthritis, HipFrance
-
Stryker Australia Pty Ltd.Not yet recruitingArthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))Australia
-
Ain Shams UniversityCompletedLength of the Femoral Stem in Arthroplasty Done for Patients With Proximal Femoral Metastatic LesionArthroplasty | Metastatic Bone Tumor | Pathological FractureEgypt
-
Biomet Orthopedics, LLCTerminatedOsteoarthritis, Hip | Traumatic Arthritis of HipUnited States
-
Zimmer BiometCompletedOsteoarthritis | Rheumatoid Arthritis | Avascular Necrosis | Prosthesis FailureSwitzerland, Germany, Italy, United Kingdom
-
Stryker OrthopaedicsRecruitingRheumatoid Arthritis | Post-traumatic Osteoarthritis | Surgery | Avascular Necrosis | Femoral Neck Fractures | Hip Osteoarthritis | Trochanteric FracturesUnited States