Rotator Cuff Tear ArthropathyPhase 4NCT01873651
Longterm Outcome of the Delta III Inverse Prosthesis
A Phase 4 study testing Implantation of a Delta III Prosthesis in people with Rotator Cuff Tear Arthropathy, run by Schulthess Klinik.
Trial summary
The aim of the study is to describe the results after > 10 years due to a prosthesis implant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear Arthropathy
- What is being tested?
- Implantation of a Delta III Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Mar 2014
- Phase
- Phase 4
- 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
Who may be able to join
- implantation of a Delta III - prothesis
- timeframe (Oct 1998 - Dec 2002)
- delta-pectoral approach
- written informed consent
Who cannot join
- Implantation because of a revision
- Complaints, which make it difficult to follow instructions or even prevent
About this study
Official title: The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients
The aim of the study is to describe the results after > 10 years due to a prosthesis implant.
Read the detailed description
The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.
- Conditions
- Rotator Cuff Tear Arthropathy
- Being tested
- Implantation of a Delta III Prosthesis
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a Delta III ProsthesisDevice
Implantation of a Delta III Prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Delta III | Experimental | Implantation of a Delta III Prosthesis Receives: Device: Implantation of a Delta III Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Murley Score
Measured: 10 years
Secondary outcomes (9)
cASES
Measured: 10 years
pASES
Measured: 10 years
SF-36
Measured: 10 years
DASH-Questionannaire
Measured: 10 years
SPADI
Measured: 10 years
x-ray (Sperling Classification)
Measured: 10 years
x-ray (Sirveaux Classification)
Measured: 10 years
Description of the glenoid
Description of the situation:
e.g.
- any dissociation of the gleonid
- any migration of the glenoid
Measured: 10 years
Description of the stem
Description of the situation:
e.g.
- change of the position
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
Why it stopped: The study has been withdrawn due to too few patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Flury, Schulthess Klinik
- Investigators
- Matthias Flury, Dr., Principal investigator, Schulthess Klinik, Upper Extremities Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873651
- Sponsor's protocol ID
- Delta III
- Status last verified
- Aug 2014
- First submitted
- 5 Jun 2013
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients
- ClinicalTrials.gov ID
- NCT01873651
- Acronym / sponsor ID
- Delta III
- Conditions
- Rotator Cuff Tear Arthropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has been withdrawn due to too few patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 10 Jun 2013 (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 aim of the study is to describe the results after > 10 years due to a prosthesis implant.
Detailed description
The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delta III | Experimental | Device: Implantation of a Delta III ProsthesisImplantation of a Delta III Prosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- implantation of a Delta III - prothesis
- timeframe (Oct 1998 - Dec 2002)
- delta-pectoral approach
- written informed consent
Key exclusion criteria (2 listed)
- Implantation because of a revision
- Complaints, which make it difficult to follow instructions or even prevent
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 |
|---|---|---|
| Implantation of a Delta III ProsthesisImplantation of a Delta III Prosthesis | Device | Delta III |
Primary outcome
Constant Murley Score
Time frame: 10 years
9 secondary outcomes
cASES
Time frame: 10 years
pASES
Time frame: 10 years
SF-36
Time frame: 10 years
DASH-Questionannaire
Time frame: 10 years
SPADI
Time frame: 10 years
x-ray (Sperling Classification)
Time frame: 10 years
x-ray (Sirveaux Classification)
Time frame: 10 years
Description of the glenoid
Time frame: 10 years
Description of the stem
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Matthias Flury, Dr. principal investigator
Schulthess Klinik, Upper Extremities Department
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Implantation of a Delta III Prosthesis in people with Rotator Cuff Tear Arthropathy, run by Schulthess Klinik.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 11 Aug 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Murley Score (time frame: 10 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 11 Aug 2014.