Localized, Primary OsteoarthritisNCT02424760
Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
An observational study of Localized, Primary Osteoarthritis and Post-traumatic Arthrosis of Other Joints, Shoulder Region, run by Stryker Trauma and Extremities.
Trial summary
The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies. The rotator cuff must be functional. 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
- 67 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 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: Study population is a continuous series of the first 67 patients having received an Inspyre implant in the 8 participating sites.
Who may be able to join
- patients requiring a Humeral Head Replacement (HHR) with INSPYRE as per indication of the Instruction For Use:
- with degenerative indication such as primary Gleno Humeral (GH) osteoarthritis, post-traumatic arthritis, primary and secondary avascular osteonecrosis of the humeral head,
- presenting a functional rotator cuff,
- able to return for all scheduled and required study visit;
- having provided informed Consent about scientific study participation if applicable.
Who cannot join
- Acute proximal humeral fracture,
- Systemic or local infection,
- Rotator cuff tear,
- Instability of the humeral head,
- Axillary nerve palsy,
- Revision arthroplasty.
About this study
Official title: A Prospective Cohort Study to Document the Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies. The rotator cuff must be functional.
The aim of this study is to prospectively collect data from consecutive series to implement a Post Marketing Surveillance plan.
Read the detailed description
Degenerative shoulder pathologies associated with a functional rotator cuff are currently treated by hemi-arthroplasty or total prosthesis replacement. The choice of surgery process is mainly made according to the status of the glenoid.
Concerning hemi-arthroplasty, two types of humeral prosthesis are usually used: anatomical stems or resurfacing head implants. Both provide good results. Nevertheless with these prostheses, patient can present with post-operative pains due to glenoid erosion, linked to the metallic compounds used in such a prostheses. To face this issue, it was decided to modify the metallic compounds, and in order to mimic the tribological properties of the cartilage, Pyrocarbon (PyC) was found to be the best material.
First application of PyC in a medical device was for cardiac valves in 1969. Currently more than 2 million people live with PyC cardiac valves. Mechanical and physical properties of PyC are in favor of its use in orthopedic surgery; furthermore, its biocompatibility plays an important role in its good acceptability.
As very good results were observed when used in hand and wrist, interposition PyC implant was suggested for shoulder. Another advantage was that such interposition device allowed performing less invasive surgery, a particularly important criteria for young patients.
INSPYRE shoulder prosthesis was then designed as a shoulder interposition implant intended for partial replacement of the gleno-humeral joint. This implant is inserted between the glenoid cartilage and the humeral metaphyseal cavity. It is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies, e.g., osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, primary and secondary necrosis of the humeral head. The rotator cuff must be functional.
- 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
Also called Inspyre
What is being measured
The primary outcome is the main question the study is designed to answer.
Implants survival rates
Number of device or procedure related adverse events
Measured: up to 10 years follow-up
Secondary outcomes (3)
Change from baseline and previous visit in Constant Murley score
Measured: at 1, 2, 5 and 10 years follow-up
Change from baseline and previous visit in Range of Motion
Forward flexion, Internal rotation and external rotation will be assessed
Measured: at 3-6 months, 1, 2, 5 and 10 years follow-up
Radiographic criteria timely evolution
Glenoid erosion, tuberosities thinning, lateralization index, subacromial space and implant subsidence will be assessed according to available R-ray, CT or MRI
Measured: at 3-6 months, 1, 2, 5 and 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 posted23 Apr 2015 (estimated)
- Study startMar 2011
- Primary completionMar 2021 (estimated)
- Study completionMar 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.
- More trials run by Stryker Trauma and ExtremitiesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilles WALCH, MD, Principal investigator, Centre Orthopédique Santy, Lyon, FR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424760
- Sponsor's protocol ID
- 0907-T-INSPYRE-RM
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 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
- A Prospective Cohort Study to Document the Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
- ClinicalTrials.gov ID
- NCT02424760
- Acronym / sponsor ID
- 0907-T-INSPYRE-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
- 67 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 23 Apr 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.
The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies. The rotator cuff must be functional.
The aim of this study is to prospectively collect data from consecutive series to implement a Post Marketing Surveillance plan.
Detailed description
Degenerative shoulder pathologies associated with a functional rotator cuff are currently treated by hemi-arthroplasty or total prosthesis replacement. The choice of surgery process is mainly made according to the status of the glenoid.
Concerning hemi-arthroplasty, two types of humeral prosthesis are usually used: anatomical stems or resurfacing head implants. Both provide good results. Nevertheless with these prostheses, patient can present with post-operative pains due to glenoid erosion, linked to the metallic compounds used in such a prostheses. To face this issue, it was decided to modify the metallic compounds, and in order to mimic the tribological properties of the cartilage, Pyrocarbon (PyC) was found to be the best material.
First application of PyC in a medical device was for cardiac valves in 1969. Currently more than 2 million people live with PyC cardiac valves. Mechanical and physical properties of PyC are in favor of its use in orthopedic surgery; furthermore, its biocompatibility plays an important role in its good acceptability.
As very good results were observed when used in hand and wrist, interposition PyC implant was suggested for shoulder. Another advantage was that such interposition device allowed performing less invasive surgery, a particularly important criteria for young patients.
INSPYRE shoulder prosthesis was then designed as a shoulder interposition implant intended for partial replacement of the gleno-humeral joint. This implant is inserted between the glenoid cartilage and the humeral metaphyseal cavity. It is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies, e.g., osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, primary and secondary necrosis of the humeral head. The rotator cuff must be functional.
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
- Study population is a continuous series of the first 67 patients having received an Inspyre implant in the 8 participating sites.
Key inclusion criteria (5 listed)
- patients requiring a Humeral Head Replacement (HHR) with INSPYRE as per indication of the Instruction For Use:
- with degenerative indication such as primary Gleno Humeral (GH) osteoarthritis, post-traumatic arthritis, primary and secondary avascular osteonecrosis of the humeral head,
- presenting a functional rotator cuff,
- able to return for all scheduled and required study visit;
- having provided informed Consent about scientific study participation if applicable.
Key exclusion criteria (6 listed)
- Acute proximal humeral fracture,
- Systemic or local infection,
- Rotator cuff tear,
- Instability of the humeral head,
- Axillary 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-arthroplastyAlso: Inspyre | Device | – |
Primary outcome
Implants survival rates
Time frame: up to 10 years follow-up
Number of device or procedure related adverse events
3 secondary outcomes
Change from baseline and previous visit in Constant Murley score
Time frame: at 1, 2, 5 and 10 years follow-up
Change from baseline and previous visit in Range of Motion
Time frame: at 3-6 months, 1, 2, 5 and 10 years follow-up
Radiographic criteria timely evolution
Time frame: at 3-6 months, 1, 2, 5 and 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.
Gilles WALCH, 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 5 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?
Implants survival rates (time frame: up to 10 years 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.