Arthroplasty, Hip ReplacementNCT02338661
Clinical Observation Study With the SBG Stem
An observational study of Arthroplasty, Hip Replacement, run by Smith & Nephew Orthopaedics AG at 1 site in Switzerland.
Trial summary
This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Hip Replacement
- What is being tested?
- SBG hip stem
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2004to 24 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- patients requiring the implantation of the SBG hip stem
Who cannot join
- 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
Show all 9Show fewer
- revision of failed hip endoprosthesis
- hypersensitivity to used materials
- any conditions preventing stable anchoring of the hip prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.
- Conditions
- Arthroplasty, Hip Replacement
- Being tested
- SBG hip stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBG hip stemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
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.
Measured: Baseline and 10 years post surgery
Secondary outcomes (6)
Assessment of position of hip stem
Change in hip stem position from Baseline to 10 years post surgery.
Measured: Baseline and 10 years post surgery
Radiographic Analysis: classification of osseointegration of hip stem
Measured: 10 years post surgery
Radiographic Analysis: radiolucent lines around hip stem
Radiographic measurements will be taken of linear radiolucencies. Radiolucent lines will be measured in mm.
Measured: 10 years post surgery
Radiographic Analysis: number of participants with femoral osteolysis around hip stem
Measured: 10 years post surgery
Radiographic Analysis: bone atrophy around hip stem
Radiographic measurements will be taken of bone atrophy. Bone atrophy will be measured in mm.
Measured: 10 years post surgery
Radiographic Analysis: bone hypertrophy around hip stem
Radiographic measurements will be taken of bone hypertrophy. Bone hypertrophy will be measured in mm.
Measured: 10 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2004
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beat Schmid, Dr. med., Principal investigator, Praxis Klinik Gut Buchs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338661
- Sponsor's protocol ID
- D8319
- Status last verified
- Apr 2018
- First submitted
- 12 Dec 2014
- Last updated
- 1 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation Study With the SBG Stem
- ClinicalTrials.gov ID
- NCT02338661
- Acronym / sponsor ID
- D8319
- Conditions
- Arthroplasty, Hip Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- patients requiring the implantation of the SBG hip stem
Key exclusion criteria (9 listed)
- general medical contraindications to surgery
- acute or recent infection of joint
- atrophy or deformation of upper femur
- muscular atrophy or neuromuscular disease
- pathologic fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBG hip stem | Device | – |
Primary outcome
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.
6 secondary outcomes
Assessment of position of hip stem
Time frame: Baseline and 10 years post surgery
Radiographic Analysis: classification of osseointegration of hip stem
Time frame: 10 years post surgery
Radiographic Analysis: radiolucent lines around hip stem
Time frame: 10 years post surgery
Radiographic Analysis: number of participants with femoral osteolysis around hip stem
Time frame: 10 years post surgery
Radiographic Analysis: bone atrophy around hip stem
Time frame: 10 years post surgery
Radiographic Analysis: bone hypertrophy around hip stem
Time frame: 10 years post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beat Schmid, Dr. med. principal investigator
Praxis Klinik Gut Buchs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Hip Replacement, run by Smith & Nephew Orthopaedics AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (time frame: Baseline and 10 years post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.