Idiopathic OsteoarthritisNCT02754024
Humeral Head Implants: Radiological and Clinical Evaluation
An observational study of Idiopathic Osteoarthritis and Posttraumatic Osteoarthritis, run by Werner Anderl.
Trial summary
In the past years several shoulder reconstruction systems with different types of prostheses and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a wide range of pathologies and revision situations. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Osteoarthritis, Posttraumatic Osteoarthritis, Humeral Head Necrosis
- What is being tested?
- Total shoulder arthroplasty (TSA), Hemi shoulder arthroplasty (HSA) and Eclipse™ (Arthrex Inc., Naples, FL, USA)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Sep 2025
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring hemi- or total shoulder arthroplasty
Who may be able to join
- Age 40 to 85 years at time of surgery
- Patients with primary or secondary osteoarthritis of the shoulder
Who cannot join
- Patients with cuff tear arthropathy and axillary nerve lesions
About this study
In the past years several shoulder reconstruction systems with different types of prostheses and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a wide range of pathologies and revision situations. The aim of the present study is to report radiological and clinical outcome with a stemless shoulder implant with hollow screw fixation.
- Conditions
- Idiopathic Osteoarthritis, Posttraumatic Osteoarthritis, Humeral Head Necrosis, Instability Arthritis
- Being tested
- Total shoulder arthroplasty (TSA), Hemi shoulder arthroplasty (HSA), Eclipse™ (Arthrex Inc., Naples, FL, USA)
- Keywords
- Stemless shoulder prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total shoulder arthroplasty (TSA)Procedure or surgery
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)
Hemi shoulder arthroplasty (HSA)Procedure or surgery
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)
Eclipse™ (Arthrex Inc., Naples, FL, USA)Device
stemless humeral head implant
| Study group | Role | What they receive |
|---|---|---|
| Total shoulder arthroplasty (TSA) | Replacement of humeral head and glenoid Receives: Procedure: Total shoulder arthroplasty (TSA); Device: Eclipse™ (Arthrex Inc., Naples, FL, USA) | |
| Hemi shoulder arthroplasty (HSA) | Replacement of humeral head only Receives: Procedure: Hemi shoulder arthroplasty (HSA); Device: Eclipse™ (Arthrex Inc., Naples, FL, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Constant score
The Constant score is a validated outcome score assessing pain and function of the shoulder
Measured: 5 years
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
Measured: 5 years
Secondary outcomes (7)
the Constant score
Measured: Change from baseline to 2 years postimplantation
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
Measured: 2 years
the Constant score
Measured: Change from baseline to 5 years postimplantation
the Constant score
Measured: 10 years
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
Measured: 10 years
the Constant score
Measured: 15-20 years
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
Measured: 15-20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startSep 2005
- Primary completionMar 2016
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Werner Anderl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Werner Anderl, Austrian Research Group for Regenerative and Orthopedic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754024
- Sponsor's protocol ID
- HHI
- Status last verified
- Jul 2020
- First submitted
- 21 Apr 2016
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Heuberer PR, Brandl G, Pauzenberger L, Laky B, Kriegleder B, Anderl W. Radiological changes do not influence clinical mid-term outcome in stemless humeral head replacements with hollow screw fixation: a prospective radiological and clinical evaluation. BMC Musculoskelet Disord. 2018 Jan 22;19(1):28. doi: 10.1186/s12891-018-1945-6.
PubMed 29357861
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humeral Head Implants: Radiological and Clinical Evaluation
- ClinicalTrials.gov ID
- NCT02754024
- Acronym / sponsor ID
- HHI
- Conditions
- Idiopathic Osteoarthritis, Posttraumatic Osteoarthritis, Humeral Head Necrosis, Instability Arthritis
- Keywords
- Stemless shoulder prosthesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Werner AnderlUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 28 Apr 2016 (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.
In the past years several shoulder reconstruction systems with different types of prostheses and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a wide range of pathologies and revision situations. The aim of the present study is to report radiological and clinical outcome with a stemless shoulder implant with hollow screw fixation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total shoulder arthroplasty (TSA) | – | Procedure: Total shoulder arthroplasty (TSA), Device: Eclipse™ (Arthrex Inc., Naples, FL, USA)Replacement of humeral head and glenoid |
| Hemi shoulder arthroplasty (HSA) | – | Procedure: Hemi shoulder arthroplasty (HSA), Device: Eclipse™ (Arthrex Inc., Naples, FL, USA)Replacement of humeral head only |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring hemi- or total shoulder arthroplasty
Key inclusion criteria (2 listed)
- Age 40 to 85 years at time of surgery
- Patients with primary or secondary osteoarthritis of the shoulder
Key exclusion criteria (1 listed)
- Patients with cuff tear arthropathy and axillary nerve lesions
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 |
|---|---|---|
| Total shoulder arthroplasty (TSA)stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA) | Procedure or surgery | Total shoulder arthroplasty (TSA) |
| Hemi shoulder arthroplasty (HSA)stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA) | Procedure or surgery | Hemi shoulder arthroplasty (HSA) |
| Eclipse™ (Arthrex Inc., Naples, FL, USA)stemless humeral head implant | Device | Hemi shoulder arthroplasty (HSA), Total shoulder arthroplasty (TSA) |
Primary outcome
the Constant score
Time frame: 5 years
The Constant score is a validated outcome score assessing pain and function of the shoulder
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
Time frame: 5 years
7 secondary outcomes
the Constant score
Time frame: Change from baseline to 2 years postimplantation
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
Time frame: 2 years
the Constant score
Time frame: Change from baseline to 5 years postimplantation
the Constant score
Time frame: 10 years
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
Time frame: 10 years
the Constant score
Time frame: 15-20 years
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
Time frame: 15-20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 29357861Heuberer PR, Brandl G, Pauzenberger L, Laky B, Kriegleder B, Anderl W. Radiological changes do not influence clinical mid-term outcome in stemless humeral head replacements with hollow screw fixation: a prospective radiological and clinical evaluation. BMC Musculoskelet Disord. 2018 Jan 22;19(1):28. doi: 10.1186/s12891-018-1945-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Osteoarthritis and Posttraumatic Osteoarthritis, run by Werner Anderl.
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 2 inclusion and 1 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 14 Jul 2020. 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?
the Constant score (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02754024, which also lists 1 linked publication.
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 14 Jul 2020.