OsteoarthritisNCT00719771
Global® AP™ Total Shoulder Arthroplasty
A study testing Global® AP™ Total shoulder arthroplasty in people with Osteoarthritis, run by DePuy Orthopaedics at 4 sites in United States.
Trial summary
This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Global® AP™ Total shoulder arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2008to Oct 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.
Who cannot join
- Are under 18 years of age or over 70
- Diagnosis of AVN, Inflammatory Arthritis, Fracture or Malunion.
- Have a hemi-arthroplasty
- Have destruction of the proximal humerus that precludes rigid fixation of the humeral component
- Have arthritis with insufficient cuff tissue
- Have had a failed rotator cuff surgery
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- Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
- Have evidence of active infection
- Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - Have a known active metastatic or neoplastic disease
- Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol
- Are skeletally immature.
- Have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products
- Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible
- Are currently participating in another clinical study
- Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
- Are currently involved in any personal injury litigation, medical legal or worker's compensation claims.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mission Hospitals Research Institute
Asheville, North Carolina, 28801
Wellington Orthopaedics and Sports Medicine
Cincinnati, Ohio, 45230
Rosenberg Cooley Metcalf Clinic
Park City, Utah, 84060
The CORE Institute
Phoenix, Arizona, 85027
About this study
Official title: A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty
This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.
Read the detailed description
The purpose of the study is to determine the difference between pre-operative and post-operative levels of patient satisfaction, shoulder function, radiographic alignment, shoulder pain and patient satisfaction in patients receiving a Global® AP™ shoulder prosthesis for glenohumeral arthritis.
- Conditions
- Osteoarthritis
- Being tested
- Global® AP™ Total shoulder arthroplasty
- Keywords
- Osteoarthritis, Glenohumeral joint, Glenoid, Shoulder arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global® AP™ Total shoulder arthroplastyDevice
Also called Global® AP™ Shoulder
Total shoulder arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Global® AP™ Shoulder | Other | Global® AP™ Shoulder Receives: Device: Global® AP™ Total shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Shoulder Score
Measured: Pre-op, 6, 12, 24 months
Secondary outcomes (4)
SF-12
Measured: Pre-op, 6,12, 24 months
Penn/ASES
Measured: Pre-Op, 6, 12, and 24 months
Radiographic Data
Measured: Pre-Op, 6 weeks, 6, 12, and 24 months
Quality of Life Survey
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Himden, BA, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719771
- Sponsor's protocol ID
- 05071
- Status last verified
- Dec 2013
- First submitted
- 21 Jul 2008
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT00719771
- Acronym / sponsor ID
- 05071
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Glenohumeral joint, Glenoid, Shoulder arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Jul 2008 (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 study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.
Detailed description
The purpose of the study is to determine the difference between pre-operative and post-operative levels of patient satisfaction, shoulder function, radiographic alignment, shoulder pain and patient satisfaction in patients receiving a Global® AP™ shoulder prosthesis for glenohumeral arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Global® AP™ Shoulder | Other | Device: Global® AP™ Total shoulder arthroplastyGlobal® AP™ Shoulder |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.
Key exclusion criteria (16 listed)
- Are under 18 years of age or over 70
- Diagnosis of AVN, Inflammatory Arthritis, Fracture or Malunion.
- Have a hemi-arthroplasty
- Have destruction of the proximal humerus that precludes rigid fixation of the humeral component
- Have arthritis with insufficient cuff tissue
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 |
|---|---|---|
| Global® AP™ Total shoulder arthroplastyAlso: Global® AP™ ShoulderTotal shoulder arthroplasty | Device | Global® AP™ Shoulder |
Primary outcome
Constant Shoulder Score
Time frame: Pre-op, 6, 12, 24 months
4 secondary outcomes
SF-12
Time frame: Pre-op, 6,12, 24 months
Penn/ASES
Time frame: Pre-Op, 6, 12, and 24 months
Radiographic Data
Time frame: Pre-Op, 6 weeks, 6, 12, and 24 months
Quality of Life Survey
Time frame: 6 weeks
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 22 May 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 Himden, BA study director
DePuy Orthopaedics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global® AP™ Total shoulder arthroplasty in people with Osteoarthritis, run by DePuy Orthopaedics at 4 sites 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 1 inclusion and 16 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Constant Shoulder Score (time frame: Pre-op, 6, 12, 24 months). 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 22 May 2014.