Primary and Secondary CoxarthrosisNCT04172129
Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study
An observational study of Primary and Secondary Coxarthrosis and Dysplasia Coxarthrosis, run by Smith & Nephew Orthopaedics AG at 1 site in Germany.
Trial summary
The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith \& Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Primary and Secondary Coxarthrosis, Dysplasia Coxarthrosis, Post-traumatic Necrosis of the Femoral Head
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 26 Apr 2011to 15 Feb 2017
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients identified in the primary care clinic with need for total hip arthroplasty
Who may be able to join
- Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required.
- Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations.
- Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function.
- Subject was 30 to 65 (inclusive) years of age at time of surgery.
Who cannot join
- Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery.
- Subject had a local or systemic infection.
- Subject had previously diagnosed osteoporosis.
- Subject had a femoral neck angle of >145°.
- Subject had a femoral neck angle of <125°.
- Subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (American Society of Anaesthesiologists' (ASA) Score 3 or 4).
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- Subject had a documented allergy against elements of the implanted device.
- Subject had a neurological disease with changed motor function.
- Subject was pregnant.
- Subject had a Body Mass Index (BMI) > 30.
- Subject suffered from alcoholism or addictive disorders.
- Subject needed a revision hip arthroplasty.
- Subject had an insufficient command of the language to understand patient information and consent.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Orthopädische Klinik der Medizinischen Hochschule Hannover
Hanover, 30625
About this study
The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith \& Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).
- Conditions
- Primary and Secondary Coxarthrosis, Dysplasia Coxarthrosis, Post-traumatic Necrosis of the Femoral Head
- Being tested
- Total Hip Arthroplasty
- Keywords
- Nanos, THA, MBRSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| NANOS | NANOS™ Neck Preserving Hip Stem Receives: Device: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of migration pattern of the Nanos stem
Measuring migration used the model-based RSA method
Measured: 2 years
Change in quality of life
Measuring change in quality of life using the Short Form (SF) 36 Mental Component Score
- Minimum Value: 0 (worst outcome)
- Maximum Value: 100 (best outcome)
Measured: 2 years
Secondary outcomes (7)
Harris Hip Score
Investigator assessed outcome score Minimum: 0 (worst outcome) Maximum: 100 (best outcome)
Measured: 2 years
University of California, Los Angeles (UCLA) scale
Score rating the patient's current activity level
- Minimum: 1 (wholly inactive subject)
- Maximum: 10 (totally active subject)
Measured: 2 years
Pain Visual Analogue Scale
Score representing patient's current pain intensity
- Minimum: 0 (no pain)
- Maximum: 100 (very severe pain)
Measured: 2 years
Postel Merle d'Aubigné-Score
Score grading the functional value of the hip
- Minimum: 0 (worst outcome)
- Maximum: 6 ( best outcome)
Grading is done in each of the three dimensions: pain, mobility and ability to walk.
Measured: 2 years
Hip Disability and Ostheoarthritis Outcome Score
Patient reported outcome
- Minimum: 0 (best outcome)
- Maximum: 96 (worst outcome)
Measured: 2 years
Radiographic Evaluation
Evaluation of radiographic images regarding implant position, implant fixation, heterotopic ossifications (HO), radiolucencies, osteolysis, atrophy and hypertrophy
Measured: 2 years
Number of adverse events
Collection of adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start26 Apr 2011
- Primary completion4 Jan 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary and Secondary CoxarthrosisStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henning Windhagen, Prof. Dr. med., Principal investigator, Orthopädische Klinik der Medizinischen Hochschule Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172129
- Sponsor's protocol ID
- R11014-3-D
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04172129
- Acronym / sponsor ID
- R11014-3-D
- Conditions
- Primary and Secondary Coxarthrosis, Dysplasia Coxarthrosis, Post-traumatic Necrosis of the Femoral Head
- Keywords
- Nanos, THA, MBRSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2011 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 21 Nov 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 primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith \& Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NANOS | – | Device: Total Hip ArthroplastyNANOS™ Neck Preserving Hip Stem |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients identified in the primary care clinic with need for total hip arthroplasty
Key inclusion criteria (4 listed)
- Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required.
- Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations.
- Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function.
- Subject was 30 to 65 (inclusive) years of age at time of surgery.
Key exclusion criteria (13 listed)
- Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery.
- Subject had a local or systemic infection.
- Subject had previously diagnosed osteoporosis.
- Subject had a femoral neck angle of >145°.
- Subject had a femoral neck angle of <125°.
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 | Device | NANOS |
Primary outcome
Evaluation of migration pattern of the Nanos stem
Time frame: 2 years
Measuring migration used the model-based RSA method
Change in quality of life
Time frame: 2 years
Measuring change in quality of life using the Short Form (SF) 36 Mental Component Score * Minimum Value: 0 (worst outcome) * Maximum Value: 100 (best outcome)
7 secondary outcomes
Harris Hip Score
Time frame: 2 years
University of California, Los Angeles (UCLA) scale
Time frame: 2 years
Pain Visual Analogue Scale
Time frame: 2 years
Postel Merle d'Aubigné-Score
Time frame: 2 years
Hip Disability and Ostheoarthritis Outcome Score
Time frame: 2 years
Radiographic Evaluation
Time frame: 2 years
Number of adverse events
Time frame: 2 years
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 27 Nov 2019.
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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.
Henning Windhagen, Prof. Dr. med. principal investigator
Orthopädische Klinik der Medizinischen Hochschule Hannover
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 Primary and Secondary Coxarthrosis and Dysplasia Coxarthrosis, run by Smith & Nephew Orthopaedics AG at 1 site in Germany.
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 13 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 27 Nov 2019. 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 Germany. 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?
Evaluation of migration pattern of the Nanos stem (time frame: 2 years). The study lists 2 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 27 Nov 2019.