Advanced Glenohumeral ArthritisCAPNCT00477360
Humeral Resurfacing Hemiarthroplasty
A study testing Humeral surface replacement hemiarthroplasty (CAP) in people with Advanced Glenohumeral Arthritis, run by University of Calgary at 1 site in Canada.
Trial summary
The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Glenohumeral Arthritis
- What is being tested?
- Humeral surface replacement hemiarthroplasty (CAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Pre-Operative Inclusion Criteria:
- Failed standard non-surgical management (analgesics, nsaids, physiotherapy, activity modification)
- Persistent pain and disability for at least 6 months
- Imaging demonstrates advanced humeral head cartilage loss
Pre-Operative Exclusion Criteria:
- Active or systemic joint infection
- Significant muscle paralysis of shoulder girdle
- Charcot's Arthropathy
- Major medical illness (life expectancy <2years)
- Unable to speak and read English/French
- Psychiatric illness that precludes informed consent
- Unwilling/unable to remain in study for one year
Intra-Operative Inclusion Criteria:
Advanced humeral head cartilage loss AND ONE of:
- minimal/no glenoid cartilage loss
- complete glenoid cartilage loss and no bony erosion
- complete glenoid cartilage loss and concentric bony erosion with no humeral anterior/posterior subluxation
Intra-Operative Exclusion Criteria:
- Eccentric glenoid erosion with biconcavity of glenoid and subluxation of humeral head
- Inability of humeral head to support the CAP surface replacement
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary Sport Medicine Centre
Calgary, Alberta, T2N 1N4
About this study
Official title: Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study
The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.
Read the detailed description
Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.
- Conditions
- Advanced Glenohumeral Arthritis
- Being tested
- Humeral surface replacement hemiarthroplasty (CAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humeral surface replacement hemiarthroplasty (CAP)Device
C.A.P hemiarthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | C.A.P Receives: Device: Humeral surface replacement hemiarthroplasty (CAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder And Elbow Surgeons Shoulder Index (ASES)
Measured: 24 months post-operative
Secondary outcomes (4)
Constant Score
Measured: 24 months post-operative
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Measured: 24 months post-operative
Simple Shoulder Test (SST)
Measured: 24 months post-operative
Radiographic Evaluation
Measured: 3 months + yearly post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Glenohumeral ArthritisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International, Johnson & Johnson
- Investigators
- Dr. Richard Boorman, Principal investigator, University of CalgaryDr. Dianne Bryant, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477360
- Sponsor's protocol ID
- 15052007
- Acronym
- CAP
- Status last verified
- Aug 2011
- First submitted
- 22 May 2007
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT00477360
- Acronym / sponsor ID
- CAP / 15052007
- Conditions
- Advanced Glenohumeral Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- DePuy International, Johnson & Johnson
- Study start
- Jan 2007
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 23 May 2007 (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 primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.
Detailed description
Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Humeral surface replacement hemiarthroplasty (CAP)C.A.P |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Humeral surface replacement hemiarthroplasty (CAP)C.A.P hemiarthroplasty | Device | 1 |
Primary outcome
American Shoulder And Elbow Surgeons Shoulder Index (ASES)
Time frame: 24 months post-operative
4 secondary outcomes
Constant Score
Time frame: 24 months post-operative
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Time frame: 24 months post-operative
Simple Shoulder Test (SST)
Time frame: 24 months post-operative
Radiographic Evaluation
Time frame: 3 months + yearly post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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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.
Dr. Richard Boorman principal investigator
University of Calgary
Dr. Dianne Bryant principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humeral surface replacement hemiarthroplasty (CAP) in people with Advanced Glenohumeral Arthritis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2011. 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 Canada. 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?
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 Shoulder Index (ASES) (time frame: 24 months post-operative). 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 11 Aug 2011.