Shoulder Arthritis OsteoarthritisNCT02029469
Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study
A study testing Ascension HRA device in people with Shoulder Arthritis Osteoarthritis and Rheumatoid Arthritis Shoulder, run by Ascension Orthopedics, Inc. at 1 site in United States.
Trial summary
It is 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Arthritis Osteoarthritis, Rheumatoid Arthritis Shoulder, Acquired Deformity of Head
- What is being tested?
- Ascension HRA device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2014
- Phase
- Interventional
- 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
Who may be able to join
- 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;
- Has an intact or reparable rotator cuff;
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- 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
- The following patients will be excluded from the study - Patients who:
- 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;
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- 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
It is 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.
Read the detailed description
At each assessment interval, information on complications and adverse events will be collected. In addition, shoulder joint range of motion will be collected, and implants will be evaluated radiographically to determine joint position and assess implant with regards to radiolucencies, subsidence and subluxation (migration). Patient satisfaction with regard to the effect of the implant on shoulder function, joint pain, and overall satisfaction will be assessed using a visual analog scale (VAS). Furthermore, if there are any implant revisions during the 10-year follow-up for any of the patients enrolled in the study, the implant and/or surrounding tissue will be harvested if possible and submitted for histopathological examination.
- Conditions
- Shoulder Arthritis Osteoarthritis, Rheumatoid Arthritis Shoulder, Acquired Deformity of Head, Post-traumatic Arthrosis of Other Joints, Shoulder Region
- Being tested
- Ascension HRA device
- Keywords
- Humeral Resurfacing, Humeral Resurfacing Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascension HRA deviceDevice
Also called Ascension Metal HRA device
Patients who are treated with the Ascension® HRA for resurfacing of humeral head.
| Study group | Role | What they receive |
|---|---|---|
| HRA Device | Experimental | Patients who will be treated with Ascension HRA device. Receives: Device: Ascension HRA device |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeon Score
The ASES score will be evaluated at 2 years and compared to baseline.
Measured: Outcome data will be evaluated at 2 years
Secondary outcomes (4)
Range of Motion
Shoulder range of motion will be measured compared to baseline.
Measured: 2 years
VAS scale for pain
VAS score for pain will be evaluated at 2 years and compared to baseline.
Measured: 2 years
AP and axillary radiographs
Radiographs will be evaluated at 2 years for subsidence, lucent lines and evidence of movement or pending failure.
Measured: 2 years
Adverse events
AEs will be assessed at each study timepoint
Measured: 2 years and during entire trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startOct 2007
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Study was terminated due to PI leaving the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Arthritis 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascension Orthopedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Hakki, M.D., Principal investigator, Bay Pines VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029469
- Sponsor's protocol ID
- CP- HRA-001
- Status last verified
- Aug 2014
- First submitted
- 25 Apr 2012
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study
- ClinicalTrials.gov ID
- NCT02029469
- Acronym / sponsor ID
- CP- HRA-001
- Conditions
- Shoulder Arthritis Osteoarthritis, Rheumatoid Arthritis Shoulder, Acquired Deformity of Head, Post-traumatic Arthrosis of Other Joints, Shoulder Region
- Keywords
- Humeral Resurfacing, Humeral Resurfacing Arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to PI leaving the institution
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ascension Orthopedics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Jan 2014 (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.
It is 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.
Detailed description
At each assessment interval, information on complications and adverse events will be collected. In addition, shoulder joint range of motion will be collected, and implants will be evaluated radiographically to determine joint position and assess implant with regards to radiolucencies, subsidence and subluxation (migration). Patient satisfaction with regard to the effect of the implant on shoulder function, joint pain, and overall satisfaction will be assessed using a visual analog scale (VAS). Furthermore, if there are any implant revisions during the 10-year follow-up for any of the patients enrolled in the study, the implant and/or surrounding tissue will be harvested if possible and submitted for histopathological examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRA Device | Experimental | Device: Ascension HRA devicePatients who will be treated with Ascension HRA device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The following patient will be included in the study - Patient who:
Key exclusion criteria (9 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 |
|---|---|---|
| Ascension HRA deviceAlso: Ascension Metal HRA devicePatients who are treated with the Ascension® HRA for resurfacing of humeral head. | Device | HRA Device |
Primary outcome
American Shoulder and Elbow Surgeon Score
Time frame: Outcome data will be evaluated at 2 years
The ASES score will be evaluated at 2 years and compared to baseline.
4 secondary outcomes
Range of Motion
Time frame: 2 years
VAS scale for pain
Time frame: 2 years
AP and axillary radiographs
Time frame: 2 years
Adverse events
Time frame: 2 years and during entire trial
Results and safety
The study was stopped early (reason given: Study was terminated due to PI leaving the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
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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.
Sam Hakki, M.D. principal investigator
Bay Pines VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascension HRA device in people with Shoulder Arthritis Osteoarthritis and Rheumatoid Arthritis Shoulder, run by Ascension Orthopedics, Inc. 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 11 inclusion and 9 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 18 Aug 2014. 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: Study was terminated due to PI leaving the institution). 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 Surgeon Score (time frame: Outcome data will be evaluated at 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 18 Aug 2014.