Localized, Primary OsteoarthritisNCT02444299
Aequalis Resurfacing Head Study
An observational study of Localized, Primary Osteoarthritis and Post-traumatic Arthrosis of Other Joints, Shoulder Region, run by Stryker Trauma and Extremities.
Trial summary
Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007. The aim of this study is to collect immediate medium and long term data on performance and safety of the implant, retrospectively as well as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- What is being tested?
- Shoulder hemi-arthroplasty
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Apr 2021
- 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: Patients will be selected from 6 centers in Europe where shoulder arthroplasty with Aequalis® Resurfacing Head is performed. The first 100 patients treated in the centers will be included then followed-up, until the 10 years follow-up visit.
Who may be able to join
- Patient has received an Aequalis® Resurfacing Head implant as per the manufacturer's instructions (including the recommended indication): degenerative indication such as primary osteoarthritis, secondary osteoarthritis (post-traumatic post instability), avascular osteonecrosis of the humeral head ;
- with a functional rotator cuff ;
- has clinical and radiographic follow-up data available ;
- is informed about the study and has provided Informed Consent as applicable.
Who cannot join
- Patient with proximal humeral fracture,
- previous history of infection,
- rotator cuff tear, cuff tear arthropathy,
- significant bone loss of the glenoid (more than 25% of the articular surface),
- nerve palsy,
- revision arthroplasty.
About this study
Official title: An Observational Cohort Study Evaluating the Safety and Performance of Aequalis Resurfacing Head Implant in a Consecutive Series of Patients With Shoulder Arthroplasty
Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007.
The aim of this study is to collect immediate medium and long term data on performance and safety of the implant, retrospectively as well as prospectively, from a consecutive series of patients to assess the patients' outcomes and functional status.
Read the detailed description
Resurfacing head implants allow restoring of the normal joint mechanics and stability of the shoulder with minimal bone resection and low peripheral fracture risk, while preserving humeral bone stock. Non cemented head implants also allow for an easy re-intervention if needed. The success of resurfacing implants largely depends on the etiology, with the best results in primary shoulder arthrosis, and the worst in post-traumatic and cuff-tear arthropathy.
The Aequalis® Resurfacing Humeral Head is designed to restore the humeral head. It shares the same indications as shoulder arthroplasty in general, including the various types of arthritis and conditions resulting in loss of joint cartilage, joint incongruity, pain, and stiffness. Resurfacing humeral head implants allow minimal bone resection while preserving humeral bone stock as compared to standard anatomic humeral implants.
However, few data are available on mid-term effects of the resurfacing head implant developed by Tornier. This Post-Marketing study is implemented for the Aequalis® Resurfacing Head in shoulder arthroplasty to collect medium and long-term clinical data on performance and safety. It is designed to collect data from consecutive series in European patients for at least 12 months of follow-up and up to 10 years. If possible, the study duration and collection of information will be prolonged. Further follow-up can be implemented, by amendments.
- Conditions
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- Being tested
- Shoulder hemi-arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder hemi-arthroplastyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate
Number or device or procedure related adverse events
Measured: up to 10-year follow-up
Secondary outcomes (3)
Change from baseline and previous visit in Constant Murley score
Measured: at 3-month, 1, 2, 5, 10 years follow-up
Change from baseline and previous visit in Range Of Motion
Passive and active Abduction, external rotation and internal rotation will be assessed.
Measured: at 3-month, 1, 2, 5, 10 years follow-up
Change from baseline and previous visit in SSV.
The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Measured: at 3-month, 1, 2, 5, 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2011
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized, 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lionel NEYTON, MD, Principal investigator, Centre Orthopédique Santy, Lyon, FR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444299
- Sponsor's protocol ID
- 0908-T-RESURF-RM
- Status last verified
- Apr 2018
- First submitted
- 12 May 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study Evaluating the Safety and Performance of Aequalis Resurfacing Head Implant in a Consecutive Series of Patients With Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT02444299
- Acronym / sponsor ID
- 0908-T-RESURF-RM
- Conditions
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 14 May 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.
Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007.
The aim of this study is to collect immediate medium and long term data on performance and safety of the implant, retrospectively as well as prospectively, from a consecutive series of patients to assess the patients' outcomes and functional status.
Detailed description
Resurfacing head implants allow restoring of the normal joint mechanics and stability of the shoulder with minimal bone resection and low peripheral fracture risk, while preserving humeral bone stock. Non cemented head implants also allow for an easy re-intervention if needed. The success of resurfacing implants largely depends on the etiology, with the best results in primary shoulder arthrosis, and the worst in post-traumatic and cuff-tear arthropathy.
The Aequalis® Resurfacing Humeral Head is designed to restore the humeral head. It shares the same indications as shoulder arthroplasty in general, including the various types of arthritis and conditions resulting in loss of joint cartilage, joint incongruity, pain, and stiffness. Resurfacing humeral head implants allow minimal bone resection while preserving humeral bone stock as compared to standard anatomic humeral implants.
However, few data are available on mid-term effects of the resurfacing head implant developed by Tornier. This Post-Marketing study is implemented for the Aequalis® Resurfacing Head in shoulder arthroplasty to collect medium and long-term clinical data on performance and safety. It is designed to collect data from consecutive series in European patients for at least 12 months of follow-up and up to 10 years. If possible, the study duration and collection of information will be prolonged. Further follow-up can be implemented, by amendments.
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
- Patients will be selected from 6 centers in Europe where shoulder arthroplasty with Aequalis® Resurfacing Head is performed. The first 100 patients treated in the centers will be included then followed-up, until the 10 years follow-up visit.
Key inclusion criteria (4 listed)
- Patient has received an Aequalis® Resurfacing Head implant as per the manufacturer's instructions (including the recommended indication): degenerative indication such as primary osteoarthritis, secondary osteoarthritis (post-traumatic post instability), avascular osteonecrosis of the humeral head ;
- with a functional rotator cuff ;
- has clinical and radiographic follow-up data available ;
- is informed about the study and has provided Informed Consent as applicable.
Key exclusion criteria (6 listed)
- Patient with proximal humeral fracture,
- previous history of infection,
- rotator cuff tear, cuff tear arthropathy,
- significant bone loss of the glenoid (more than 25% of the articular surface),
- nerve palsy,
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 |
|---|---|---|
| Shoulder hemi-arthroplasty | Device | – |
Primary outcome
Implant survival rate
Time frame: up to 10-year follow-up
Number or device or procedure related adverse events
3 secondary outcomes
Change from baseline and previous visit in Constant Murley score
Time frame: at 3-month, 1, 2, 5, 10 years follow-up
Change from baseline and previous visit in Range Of Motion
Time frame: at 3-month, 1, 2, 5, 10 years follow-up
Change from baseline and previous visit in SSV.
Time frame: at 3-month, 1, 2, 5, 10 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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.
Lionel NEYTON, MD principal investigator
Centre Orthopédique Santy, Lyon, FR
Questions about this trial
What is this clinical trial studying?
An observational study of Localized, Primary Osteoarthritis and Post-traumatic Arthrosis of Other Joints, Shoulder Region, run by Stryker Trauma and Extremities.
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 6 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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Implant survival rate (time frame: up to 10-year follow-up). 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 16 Apr 2019.