Joint DiseasesSMF-S&ENCT02471703
Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem
An observational study of Joint Diseases, run by Smith & Nephew, Inc. at 6 sites in 3 countries.
Trial summary
This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Joint Diseases
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 27 Feb 2008to 1 Feb 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring total hip replacement.
Who may be able to join
- Patient presents with non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis of or any of it's composite diagnosis.
- Patient is of legal age to consent, is skeletally mature and at least 18 years old.
- Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
- Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.
Who cannot join
- Patient has poor bone stock and would make the procedure unjustifiable: A) patients which are under medical care for osteoporosis (taking hormones, Calcitonin or biphosphates) or for other metabolic pathologies, which could influence the quality of the bone (for example hyperparathyroidism, hyperthyreoidismus and osteomalacie) will be excluded from the study. B) patients suffering from Morbus Paget (osteodystrophia deformans) will be excluded from the study.
- Patient has conditions that tend to place increased loads on implants such as weight, chargot joint, muscular deficiencies and activity level, which are incompatible with a satisfactory long-term result: A) patients with a BMI > 40 will be excluded from the study B) patients participating in high-impact sports like baseball, basketball, football, handball, hockey, karate, racquet-ball, running, soccer, water skiing or similar impact sports will be excluded from the study.
- Patient is over the age of 75.
- Skeletal immaturity: patients must be at least 18 years at the time of the operation.
- Patient has an active, local infection that would lead to increased bone resorption.
- Mental or neurological conditions that tend to pre-empt the patient's ability or willingness to restrict activities.
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- Known sensitivity to materials of the implant.
- Patient is pregnant or plans to be come pregnant during the course of the study.
- Patient is a prisoner.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Canada3 sites
Hopital Maisonneuve Rosemont, Hmr
Montreal, Quebec, 5701
CHUQ-L'Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6
St. Michael's Hospital
Toronto, Ontario, M5C1R6
Germany2 sites
St. Vincenz Hospital
Brakel, 22024
Brüderkrankenhaus St. Josef
Paderborn, 33098
About this study
Official title: Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem A Prospective, Consecutive Series, Multi-center Clinical Study
This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.
Read the detailed description
The objectives of this study are to evaluate the safety and efficacy of the study device. This study will document any device-related, surgical or post-operative complication and adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems. Outcome measures will be quantified through statistical analysis of study device , HOOS questionnaire, radiographic assessments, Harris Hip Score, and adverse event reports.
- Conditions
- Joint Diseases
- Being tested
- Total hip arthroplasty
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Inflammatory Joint Disease, Non-Inflammatory Joint Disease
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyDevice
Also called Total hip replacement
Total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| SMF mini-stem hip replacement recipient | Received the device via total hip arthroplasty Receives: Device: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision of the study device
Instances of required revision of the study device
Measured: Discharge through 10 years
Device related Adverse Events
surgical, device-related, death and serious adverse events will be analyzed
Measured: Implant through 10 years
Harris Hip Score
Questionnaire to calculate pain, walking abilities, activities, degrees of hip motion
Measured: Baseline through 10 years
HOOS Questionnaire
Questionnaire to calculate hip symptoms, stiffness, pain, function and quality of life
Measured: Baseline through 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study start27 Feb 2008
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Why it stopped: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the SMF S\&E study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseasesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sobia Parveen, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471703
- Sponsor's protocol ID
- 2011SMFH132_R11007-1
- Acronym
- SMF-S&E
- Status last verified
- Feb 2021
- First submitted
- 11 Jun 2015
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem A Prospective, Consecutive Series, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT02471703
- Acronym / sponsor ID
- SMF-S&E / 2011SMFH132_R11007-1
- Conditions
- Joint Diseases
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Inflammatory Joint Disease, Non-Inflammatory Joint Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the SMF S\&E study.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2008 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 15 Jun 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 is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.
Detailed description
The objectives of this study are to evaluate the safety and efficacy of the study device. This study will document any device-related, surgical or post-operative complication and adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems. Outcome measures will be quantified through statistical analysis of study device , HOOS questionnaire, radiographic assessments, Harris Hip Score, and adverse event reports.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMF mini-stem hip replacement recipient | – | Device: Total hip arthroplastyReceived the device via total hip arthroplasty |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring total hip replacement.
Key inclusion criteria (4 listed)
- Patient presents with non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis of or any of it's composite diagnosis.
- Patient is of legal age to consent, is skeletally mature and at least 18 years old.
- Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
- Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.
Key exclusion criteria (9 listed)
- Patient has poor bone stock and would make the procedure unjustifiable: A) patients which are under medical care for osteoporosis (taking hormones, Calcitonin or biphosphates) or for other metabolic pathologies, which could influence the quality of the bone (for example hyperparathyroidism, hyperthyreoidismus and osteomalacie) will be excluded from the study. B) patients suffering from Morbus Paget (osteodystrophia deformans) will be excluded from the study.
- Patient has conditions that tend to place increased loads on implants such as weight, chargot joint, muscular deficiencies and activity level, which are incompatible with a satisfactory long-term result: A) patients with a BMI > 40 will be excluded from the study B) patients participating in high-impact sports like baseball, basketball, football, handball, hockey, karate, racquet-ball, running, soccer, water skiing or similar impact sports will be excluded from the study.
- Patient is over the age of 75.
- Skeletal immaturity: patients must be at least 18 years at the time of the operation.
- Patient has an active, local infection that would lead to increased bone resorption.
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 |
|---|---|---|
| Total hip arthroplastyAlso: Total hip replacementTotal hip arthroplasty | Device | SMF mini-stem hip replacement recipient |
Primary outcome
Revision of the study device
Time frame: Discharge through 10 years
Instances of required revision of the study device
Device related Adverse Events
Time frame: Implant through 10 years
surgical, device-related, death and serious adverse events will be analyzed
Harris Hip Score
Time frame: Baseline through 10 years
Questionnaire to calculate pain, walking abilities, activities, degrees of hip motion
HOOS Questionnaire
Time frame: Baseline through 10 years
Questionnaire to calculate hip symptoms, stiffness, pain, function and quality of life
Results and safety
The study was stopped early (reason given: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the SMF S\&E study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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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.
Sobia Parveen study chair
Smith & Nephew, Inc.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Diseases, run by Smith & Nephew, Inc. at 6 sites in 3 countries.
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 4 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: stopped early, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Germany, Belgium. 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 was stopped early (reason given: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the SMF S\&E study.). Results are not available in the source record.
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?
Revision of the study device (time frame: Discharge through 10 years). The study lists 4 primary outcomes in all. 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 21 Feb 2021.