ArthritisHRANCT02369497
Ascension® Humeral Resurfacing Arthroplasty (HRA) Follow-Up Study
An observational study of Arthritis, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
This is a prospective study on the Ascension HRA device to collect data to assess the safety and effectiveness of the HRA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis
- What is being tested?
- HRA
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jul 2014
- 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 with arthritis requiring humeral resurfacing arthroplasty
Who may be able to join
- Any patient who is to be treated with the Ascension HRA is eligible for inclusion in this study. Therefore, Principal Investigators should attempt to recruit all patients at the study site who are treated with the Ascension HRA
- The following patient will be included in the study - Patient who:
- Is treated with the Ascension HRA
- Is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis
- Has mild or moderate humeral head deformity and /or limited motion
- Has post-traumatic arthritis
Show all 12Show fewer
- Has an intact or reparable rotator cuff
- Has the means and ability to return for all required study visits
- Is willing to participate in the study
- Has signed an Informed Consent Form
- Is at least 18 years of age and skeletally mature at the time of surgery
- Is less than 75 years of age at the time of surgery
Who cannot join
- Infection, sepsis, and osteomyelitis
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Rapid joint destruction, marked bone loss or bone resorption apparent on X-ray
- Revision procedures where other devices or treatments have failed
- Refuses to be in the study; or does not have the means and ability to return for all required study visits
- Currently participating in another clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
About this study
Official title: Ascension® Humeral Resurfacing Arthroplasty HRA Follow-Up Study
This is a prospective study on the Ascension HRA device to collect data to assess the safety and effectiveness of the HRA.
Read the detailed description
This study protocol will provide guidance to investigators wanting to perform a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the Ascension® HRA. Its purpose is to measure and document the outcomes associated with implanting the Ascension HRA prosthesis. Patients will be periodically assessed to collect data related to safety and effectiveness endpoints at the following intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5 year, and 10 years.
- Conditions
- Arthritis
- Being tested
- HRA
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRADevice
Humeral head resurfacing with the HRA device
| Study group | Role | What they receive |
|---|---|---|
| Primary cohort | Primary cohort of subjects who receive the HRA device. Receives: Device: HRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) Score
The American Shoulder and Elbow Score is a functional outcome tool that has been validated for various shoulder conditions
Measured: 2 years
Secondary outcomes (4)
Range of Motion
Assessment of range of motion in the shoulder
Measured: 2 years
Visual Analog Scale for pain
Patient assessed score of pain in the shoulder
Measured: 2 years
X-rays
X-rays are conducted to assess the location and placement of the HRA device in the shoulder
Measured: 2 years
Adverse events
assessment of any adverse events that occur during the trial
Measured: Surgery; 3 month, 6 month, 1 year and 2 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startDec 2007
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: PI left institution and site did not have resources to continue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Candi Langmaid, MPH, CCRP, Study director, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369497
- Sponsor's protocol ID
- CP-HRA-001
- Acronym
- HRA
- Status last verified
- Feb 2015
- First submitted
- 4 Nov 2014
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascension® Humeral Resurfacing Arthroplasty HRA Follow-Up Study
- ClinicalTrials.gov ID
- NCT02369497
- Acronym / sponsor ID
- HRA / CP-HRA-001
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution and site did not have resources to continue study
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Feb 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 study on the Ascension HRA device to collect data to assess the safety and effectiveness of the HRA.
Detailed description
This study protocol will provide guidance to investigators wanting to perform a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the Ascension® HRA. Its purpose is to measure and document the outcomes associated with implanting the Ascension HRA prosthesis. Patients will be periodically assessed to collect data related to safety and effectiveness endpoints at the following intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5 year, and 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary cohort | – | Device: HRAPrimary cohort of subjects who receive the HRA device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with arthritis requiring humeral resurfacing arthroplasty
Key inclusion criteria (12 listed)
- Any patient who is to be treated with the Ascension HRA is eligible for inclusion in this study. Therefore, Principal Investigators should attempt to recruit all patients at the study site who are treated with the Ascension HRA
- Is treated with the Ascension HRA
- Is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis
- Has mild or moderate humeral head deformity and /or limited motion
- Has post-traumatic arthritis
Key exclusion criteria (8 listed)
- Infection, sepsis, and osteomyelitis
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Rapid joint destruction, marked bone loss or bone resorption apparent on X-ray
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 |
|---|---|---|
| HRAHumeral head resurfacing with the HRA device | Device | Primary cohort |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: 2 years
The American Shoulder and Elbow Score is a functional outcome tool that has been validated for various shoulder conditions
4 secondary outcomes
Range of Motion
Time frame: 2 years
Visual Analog Scale for pain
Time frame: 2 years
X-rays
Time frame: 2 years
Adverse events
Time frame: Surgery; 3 month, 6 month, 1 year and 2 years post-op
Results and safety
The study was stopped early (reason given: PI left institution and site did not have resources to continue study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
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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.
Candi Langmaid, MPH, CCRP study director
Integra LifeSciences
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 Arthritis, run by Integra LifeSciences Corporation at 1 site in United States.
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 12 inclusion and 8 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 24 Feb 2015. 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 United States. 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: PI left institution and site did not have resources to continue 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?
American Shoulder and Elbow Surgeons (ASES) Score (time frame: 2 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 24 Feb 2015.