Primary OsteoarthritisNANOSNCT04036279
NANOS Neck Preserving Hip Stem
An observational study of Primary Osteoarthritis and Secondary Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 3 sites in 3 countries.
Trial summary
The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-term survivorship Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Osteoarthritis, Secondary Osteoarthritis, Dysplasia Osteoarthritis
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 21 Jan 2010to Mar 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinic for Orthopedics
Who may be able to join
- Patient requires Primary total hip replacement (THR) to the affected side, unilateral or bilateral. Bilateral only if >3 months after the first THR
- Patient agreed to participate in the MCO study by signing the Informed Consent form.
- Age of patient at date of surgery 18 to 65 years
- Patient is likely to comply with study follow-up requirements
Who cannot join
- Previously failed endoprosthesis and /or THR components in relevant hip
- Patient has proven osteoporosis
- Pronounced coxa valga with a femoral neck angle > 145º
- Pronounced coxa vara with a femoral neck angle < 125º
- History of infection in the affected joint; systemic infections
- Grossly insufficient femoral or acetabular bone stock in the involved hip where a revision cup is indicated
Show all 12Show fewer
- Spinal disease with neurologic movement disorders
- Alcoholism or addictive disorders
- ASA score is 3 or 4
- Body mass index (BMI) > 30
- Patient is pregnant or being pregnant during follow up intervals
- Patients understanding of the language is insufficient for understanding the Patient Information and Consent
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Prospective, Multicenter, Clinical Outcome Study of the NANOS Neck Preserving Stem in Patients With Degenerative Hip Joint Disease
The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-term survivorship
Read the detailed description
The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the NANOS neck preserving hip stem.
Effectiveness Measures:
- Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, HOOS Score [4-6], UCLA Activity Rating [7]
- Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration
Safety evaluations:
- Intra- and peri-operative device-related adverse events (AE) and complications up to discharge
- Postoperative AE up to 10 years
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Dysplasia Osteoarthritis, Avascular Femoral Neck Necrosis, Post-Traumatic Femoral Neck Necrosis, Intact Femoral Neck With Good Bone Quality
- Being tested
- Total Hip Arthroplasty
- Keywords
- NANOS, Hip, Neck Preserving Stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term survivorship of Nanos
Revision for any reason. Implant survivorship at 10 years post study procedure. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start21 Jan 2010
- Primary completionMar 2023
- Study completionMar 2023
Why it stopped: This study was originally designed to meet MDR commitments. MDR Approval was secured without this study. Therefore, this study does not fulfil its role as a regulatory body commitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary OsteoarthritisStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Turgay Efe, Dr.med, Principal investigator, Phillips University Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036279
- Sponsor's protocol ID
- R11014-1
- Acronym
- NANOS
- Status last verified
- Jun 2023
- First submitted
- 25 Jul 2019
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Clinical Outcome Study of the NANOS Neck Preserving Stem in Patients With Degenerative Hip Joint Disease
- ClinicalTrials.gov ID
- NCT04036279
- Acronym / sponsor ID
- NANOS / R11014-1
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Dysplasia Osteoarthritis, Avascular Femoral Neck Necrosis, Post-Traumatic Femoral Neck Necrosis, Intact Femoral Neck With Good Bone Quality
- Keywords
- NANOS, Hip, Neck Preserving Stem
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was originally designed to meet MDR commitments. MDR Approval was secured without this study. Therefore, this study does not fulfil its role as a regulatory body commitment.
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2010 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 29 Jul 2019 (actual)
- 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.
The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-term survivorship
Detailed description
The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the NANOS neck preserving hip stem.
Effectiveness Measures:
- Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, HOOS Score [4-6], UCLA Activity Rating [7]
- Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration
Safety evaluations:
- Intra- and peri-operative device-related adverse events (AE) and complications up to discharge
- Postoperative AE up to 10 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic for Orthopedics
Key inclusion criteria (4 listed)
- Patient requires Primary total hip replacement (THR) to the affected side, unilateral or bilateral. Bilateral only if >3 months after the first THR
- Patient agreed to participate in the MCO study by signing the Informed Consent form.
- Age of patient at date of surgery 18 to 65 years
- Patient is likely to comply with study follow-up requirements
Key exclusion criteria (12 listed)
- Previously failed endoprosthesis and /or THR components in relevant hip
- Patient has proven osteoporosis
- Pronounced coxa valga with a femoral neck angle > 145º
- Pronounced coxa vara with a femoral neck angle < 125º
- History of infection in the affected joint; systemic infections
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 Arthroplasty | Procedure or surgery | – |
Primary outcome
Long term survivorship of Nanos
Time frame: 10 years
Revision for any reason. Implant survivorship at 10 years post study procedure. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants
Results and safety
The study was stopped early (reason given: This study was originally designed to meet MDR commitments. MDR Approval was secured without this study. Therefore, this study does not fulfil its role as a regulatory body commitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Turgay Efe, Dr.med principal investigator
Phillips University Marburg, Germany
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Osteoarthritis and Secondary Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 3 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 12 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Netherlands, Poland. 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: This study was originally designed to meet MDR commitments. MDR Approval was secured without this study. Therefore, this study does not fulfil its role as a regulatory body commitment.). 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?
Long term survivorship of Nanos (time frame: 10 years). 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 7 Jun 2023.